SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="LantusInjectionLabelBundle"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionBundle"/>
</meta>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:uuid:4e455ace-94f4-4fa3-85eb-0152e5a06239"/>
</identifier>
<type value="document"/>
<timestamp value="2021-01-27T00:00:00.0000Z"/>
<entry>
<fullUrl
value="http://example.org/Composition/LantusInjectionLabelComposition"/>
<resource>
<Composition>
<id value="LantusInjectionLabelComposition"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_LantusInjectionLabelComposition"> </a><p class="res-header-id"><b>Generated Narrative: Composition LantusInjectionLabelComposition</b></p><a name="LantusInjectionLabelComposition"> </a><a name="hcLantusInjectionLabelComposition"> </a><a name="LantusInjectionLabelComposition-en-US"> </a><p><b>VersionNumber</b>: 11</p><p><b>identifier</b>: <a href="http://terminology.hl7.org/6.0.2/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt
This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid:
Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.
This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:uuid:6328c99d-d75f-43ef-b19e-7e71f91e57f6</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{http://loinc.org 34391-3}">HUMAN PRESCRIPTION DRUG LABEL</span></p><p><b>date</b>: 2021-01-27</p><p><b>author</b>: <a href="Organization-SanofiAventisUS.html">Organization sanofi-aventis U.S. LLC</a></p><p><b>title</b>: These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/>
<br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000</p></div>
</text>
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/versionNumber">
<valueString value="11"/>
</extension>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:uuid:6328c99d-d75f-43ef-b19e-7e71f91e57f6"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="http://loinc.org"/>
<code value="34391-3"/>
<display value="HUMAN PRESCRIPTION DRUG LABEL"/>
</coding>
</type>
<date value="2021-01-27"/>
<author>🔗
<reference value="Organization/SanofiAventisUS"/>
</author>
<title
value="These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/>
<br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000"/>
<section id="68224803-d32c-4438-9439-9c210668e295">
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime">
<valueDateTime value="2021-01-27"/>
</extension>
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionLinkId">
<valueString value="S1"/>
</extension>
<title value="1 INDICATIONS AND USAGE"/>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="34067-9"/>
<display value="INDICATIONS &amp; USAGE SECTION"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div style="highlights"><p>LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. (<a href="#S1">1</a>)</p><p><span style="text-decoration: underline">Limitations of Use</span></p><p>Not recommended for treating diabetic ketoacidosis. (<a href="#S1">1</a>)</p></div><div style="narrative"><a name="S1"/><p>LANTUS is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.</p></div></div>
</text>
<section id="0230cfa8-ff67-4666-ba57-bbad268ac6fe">
<code>
<coding>
<system value="http://loinc.org"/>
<code value="42229-5"/>
<display value="SPL UNCLASSIFIED SECTION"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div style="narrative"><p><span style="text-decoration: underline">Limitations of Use</span></p><p>LANTUS is not recommended for the treatment of diabetic ketoacidosis.</p></div></div>
</text>
</section>
</section>
<section id="f65bb254-5018-4af5-b02a-38d5d51ed901">
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime">
<valueDateTime value="2021-01-27"/>
</extension>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="48780-1"/>
<display value="SPL LISTING DATA ELEMENTS SECTION"/>
</coding>
</code>
<entry>🔗
<reference
value="MedicinalProductDefinition/LantusSyringeDefinition"/>
</entry>
<entry>🔗
<reference
value="MedicinalProductDefinition/LantusVialDefinition"/>
</entry>
</section>
<section id="ff673a31-f676-444c-a009-8d4a2645fd19">
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime">
<valueDateTime value="2021-01-27"/>
</extension>
<title value="PRINCIPAL DISPLAY PANEL - 10 mL Vial Package"/>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="51945-4"/>
<display value="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div style="narrative"><p>NDC 0088-5021-01<br/>Rx only</p><p>Lantus<sup>®</sup><br/>insulin glargine<br/>injection</p><p>100 units/mL<br/>(U-100)<br/>For subcutaneous<br/>injection only</p><p>Do not mix with<br/>other insulins</p><p>Use only if solution<br/>is clear and colorless<br/>with no particles visible</p><p>Use with U-100<br/>syringe only</p><p>One 10 mL multiple-dose vial</p><p>novaplus <sub>™</sub></p><img src="lantusnova-20.jpg" alt="PRINCIPAL DISPLAY PANEL - 10 mL Vial Package"/></div></div>
</text>
</section>
<section id="8ce1b409-6067-4c9d-8e21-bdb6df850c24">
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime">
<valueDateTime value="2021-01-27"/>
</extension>
<title value="PRINCIPAL DISPLAY PANEL - 3 mL Syringe Package"/>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="51945-4"/>
<display value="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div style="narrative"><p>NDC 0088-5020-05<br/>Rx only</p><p>Lantus<sup>®</sup> SoloStar<sup>®</sup><br/>insulin glargine injection<br/>For Single Patient Use Only<br/>100 units/mL (U-100)<br/>Five 3 mL Prefilled Pens</p><p>Solution for injection in a disposable insulin delivery device<br/>Do not mix with other insulins<br/>For subcutaneous injection only<br/>Use only if solution is clear and colorless with no particles visible<br/>Use within 28 days after initial use *Needles not include (see back panel)</p><p>novaplus <sub>™</sub></p><img src="lantusnova-21.jpg" alt="PRINCIPAL DISPLAY PANEL - 3 mL Syringe Package"/></div></div>
</text>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Organization/SanofiAventisUS"/>
<resource>
<Organization>
<id value="SanofiAventisUS"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedLabeler"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_SanofiAventisUS"> </a><p class="res-header-id"><b>Generated Narrative: Organization SanofiAventisUS</b></p><a name="SanofiAventisUS"> </a><a name="hcSanofiAventisUS"> </a><a name="SanofiAventisUS-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.3.6.1.4.1.519.1</code>/783243835</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-organizationTypes Labeler}">An organization that submits product labels.</span></p><p><b>name</b>: sanofi-aventis U.S. LLC</p></div>
</text>
<identifier>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="783243835"/>
</identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-organizationTypes"/>
<code value="Labeler"/>
</coding>
</type>
<name value="sanofi-aventis U.S. LLC"/>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/Organization/SanofiAventisDeutschland"/>
<resource>
<Organization>
<id value="SanofiAventisDeutschland"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_SanofiAventisDeutschland"> </a><p class="res-header-id"><b>Generated Narrative: Organization SanofiAventisDeutschland</b></p><a name="SanofiAventisDeutschland"> </a><a name="hcSanofiAventisDeutschland"> </a><a name="SanofiAventisDeutschland-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.3.6.1.4.1.519.1</code>/313218430</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-organizationTypes Establishment}">An organization that provides operations in the manufacturing of a product.</span></p><p><b>name</b>: Sanofi-Aventis Deutschland GmbH</p></div>
</text>
<identifier>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="313218430"/>
</identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-organizationTypes"/>
<code value="Establishment"/>
</coding>
</type>
<name value="Sanofi-Aventis Deutschland GmbH"/>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Organization/SanofiAventisSRL"/>
<resource>
<Organization>
<id value="SanofiAventisSRL"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_SanofiAventisSRL"> </a><p class="res-header-id"><b>Generated Narrative: Organization SanofiAventisSRL</b></p><a name="SanofiAventisSRL"> </a><a name="hcSanofiAventisSRL"> </a><a name="SanofiAventisSRL-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.3.6.1.4.1.519.1</code>/338454274</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-organizationTypes Establishment}">An organization that provides operations in the manufacturing of a product.</span></p><p><b>name</b>: Sanofi S.r.l.</p></div>
</text>
<identifier>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="338454274"/>
</identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-organizationTypes"/>
<code value="Establishment"/>
</coding>
</type>
<name value="Sanofi S.r.l."/>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/MedicinalProductDefinition/LantusSyringeDefinition"/>
<resource>
<MedicinalProductDefinition>
<id value="LantusSyringeDefinition"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_LantusSyringeDefinition"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition LantusSyringeDefinition</b></p><a name="LantusSyringeDefinition"> </a><a name="hcLantusSyringeDefinition"> </a><a name="LantusSyringeDefinition-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/6.0.2/NamingSystem-v3-ndc.html" title="National drug codes">National drug codes</a>/0088-5020</p><p><b>route</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38299}">SUBCUTANEOUS</span></p><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses active}">active</span></td><td>2017-06-04 --> (ongoing)</td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: Lantus Solostar</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes PROPRIETARY}">Proprietary Name</span></p></blockquote><blockquote><p><b>name</b></p><p><b>productName</b>: insulin glargine</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes NONPROPRIETARY}">Generic Name (Non-Proprietary)</span></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C25391}">ANALYSIS</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisDeutschland.html">Organization Sanofi-Aventis Deutschland GmbH</a></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C82401}">API MANUFACTURE</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisDeutschland.html">Organization Sanofi-Aventis Deutschland GmbH</a></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C84732}">LABEL</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisDeutschland.html">Organization Sanofi-Aventis Deutschland GmbH</a></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C43360}">MANUFACTURE</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisDeutschland.html">Organization Sanofi-Aventis Deutschland GmbH</a></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C84731}">PACK</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisDeutschland.html">Organization Sanofi-Aventis Deutschland GmbH</a></p></blockquote></div>
</text>
<identifier>
<system value="http://hl7.org/fhir/sid/ndc"/>
<value value="0088-5020"/>
</identifier>
<route>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C38299"/>
<display value="SUBCUTANEOUS"/>
</coding>
</route>
<marketingStatus>
<status>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses"/>
<code value="active"/>
</coding>
</status>
<dateRange>
<start value="2017-06-04"/>
</dateRange>
</marketingStatus>
<name>
<productName value="Lantus Solostar"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes"/>
<code value="PROPRIETARY"/>
</coding>
</type>
</name>
<name>
<productName value="insulin glargine"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes"/>
<code value="NONPROPRIETARY"/>
</coding>
</type>
</name>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C25391"/>
<display value="ANALYSIS"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C82401"/>
<display value="API MANUFACTURE"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C84732"/>
<display value="LABEL"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43360"/>
<display value="MANUFACTURE"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C84731"/>
<display value="PACK"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/MedicinalProductDefinition/LantusVialDefinition"/>
<resource>
<MedicinalProductDefinition>
<id value="LantusVialDefinition"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_LantusVialDefinition"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition LantusVialDefinition</b></p><a name="LantusVialDefinition"> </a><a name="hcLantusVialDefinition"> </a><a name="LantusVialDefinition-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/6.0.2/NamingSystem-v3-ndc.html" title="National drug codes">National drug codes</a>/0088-5021</p><p><b>route</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38299}">SUBCUTANEOUS</span></p><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses active}">active</span></td><td>2017-06-04 --> (ongoing)</td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: Lantus</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes PROPRIETARY}">Proprietary Name</span></p></blockquote><blockquote><p><b>name</b></p><p><b>productName</b>: insulin glargine</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes NONPROPRIETARY}">Generic Name (Non-Proprietary)</span></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C25391}">ANALYSIS</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisDeutschland.html">Organization Sanofi-Aventis Deutschland GmbH</a></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C82401}">API MANUFACTURE</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisDeutschland.html">Organization Sanofi-Aventis Deutschland GmbH</a></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C84732}">LABEL</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisDeutschland.html">Organization Sanofi-Aventis Deutschland GmbH</a></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C43360}">MANUFACTURE</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisDeutschland.html">Organization Sanofi-Aventis Deutschland GmbH</a></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C84731}">PACK</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisDeutschland.html">Organization Sanofi-Aventis Deutschland GmbH</a></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C25391}">ANALYSIS</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisSRL.html">Organization Sanofi S.r.l.</a></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C84732}">LABEL</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisSRL.html">Organization Sanofi S.r.l.</a></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C43360}">MANUFACTURE</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisSRL.html">Organization Sanofi S.r.l.</a></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C84731}">PACK</span></td></tr></table><p><b>organization</b>: <a href="Organization-SanofiAventisSRL.html">Organization Sanofi S.r.l.</a></p></blockquote></div>
</text>
<identifier>
<system value="http://hl7.org/fhir/sid/ndc"/>
<value value="0088-5021"/>
</identifier>
<route>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C38299"/>
<display value="SUBCUTANEOUS"/>
</coding>
</route>
<marketingStatus>
<status>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses"/>
<code value="active"/>
</coding>
</status>
<dateRange>
<start value="2017-06-04"/>
</dateRange>
</marketingStatus>
<name>
<productName value="Lantus"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes"/>
<code value="PROPRIETARY"/>
</coding>
</type>
</name>
<name>
<productName value="insulin glargine"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes"/>
<code value="NONPROPRIETARY"/>
</coding>
</type>
</name>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C25391"/>
<display value="ANALYSIS"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C82401"/>
<display value="API MANUFACTURE"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C84732"/>
<display value="LABEL"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43360"/>
<display value="MANUFACTURE"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C84731"/>
<display value="PACK"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C25391"/>
<display value="ANALYSIS"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisSRL"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C84732"/>
<display value="LABEL"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisSRL"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43360"/>
<display value="MANUFACTURE"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisSRL"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C84731"/>
<display value="PACK"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisSRL"/>
</organization>
</operation>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/ManufacturedItemDefinition/LantusSolution"/>
<resource>
<ManufacturedItemDefinition>
<id value="LantusSolution"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_LantusSolution"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition LantusSolution</b></p><a name="LantusSolution"> </a><a name="hcLantusSolution"> </a><a name="LantusSolution-en-US"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42945}">INJECTION, SOLUTION</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C42945"/>
<display value="INJECTION, SOLUTION"/>
</coding>
</manufacturedDoseForm>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusActiveIngredient"/>
<resource>
<Ingredient>
<id value="LantusActiveIngredient"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusActiveIngredient"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient LantusActiveIngredient</b></p><a name="LantusActiveIngredient"> </a><a name="hcLantusActiveIngredient"> </a><a name="LantusActiveIngredient-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-LantusSolution.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION</a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}">active ingredient - basis of strength</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="SubstanceDefinition-LantusIngredientDefinition.html">SubstanceDefinition: identifier = http://fdasis.nlm.nih.gov#Unique Ingredient Identifier (UNII)#2ZM8CX04RZ</a></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td></tr><tr><td style="display: none">*</td><td>100 iU<span style="background: LightGoldenRodYellow"> (Details: UCUM code[iU] = '[iU]')</span>/1 mL<span style="background: LightGoldenRodYellow"> (Details: UCUM codemL = 'mL')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="ACTIB"/>
</coding>
</role>
<substance>
<code>
<reference>🔗
<reference
value="SubstanceDefinition/LantusIngredientDefinition"/>
</reference>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="100"/>
<unit value="iU"/>
<system value="http://unitsofmeasure.org"/>
<code value="[iU]"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/SubstanceDefinition/LantusIngredientDefinition"/>
<resource>
<SubstanceDefinition>
<id value="LantusIngredientDefinition"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedIngredientDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_LantusIngredientDefinition"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition LantusIngredientDefinition</b></p><a name="LantusIngredientDefinition"> </a><a name="hcLantusIngredientDefinition"> </a><a name="LantusIngredientDefinition-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/6.0.2/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/2ZM8CX04RZ</p><h3>Moieties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Identifier</b></td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td><a href="http://terminology.hl7.org/6.0.2/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/2ZM8CX04RZ</td><td>INSULIN GLARGINE</td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>INSULIN GLARGINE</td></tr></table></div>
</text>
<identifier>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="2ZM8CX04RZ"/>
</identifier>
<moiety>
<identifier>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="2ZM8CX04RZ"/>
</identifier>
<name value="INSULIN GLARGINE"/>
</moiety>
<name>
<name value="INSULIN GLARGINE"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient1"/>
<resource>
<Ingredient>
<id value="LantusIngredient1"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient1"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient LantusIngredient1</b></p><a name="LantusIngredient1"> </a><a name="hcLantusIngredient1"> </a><a name="LantusIngredient1-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-LantusSolution.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION</a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass IACT}">inactive ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov J41CSQ7QDS}">ZINC</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td></tr><tr><td style="display: none">*</td><td>30 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM codeug = 'ug')</span>/1 mL<span style="background: LightGoldenRodYellow"> (Details: UCUM codemL = 'mL')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="J41CSQ7QDS"/>
<display value="ZINC"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="30"/>
<unit value="ug"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient2"/>
<resource>
<Ingredient>
<id value="LantusIngredient2"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient2"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient LantusIngredient2</b></p><a name="LantusIngredient2"> </a><a name="hcLantusIngredient2"> </a><a name="LantusIngredient2-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-LantusSolution.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION</a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass IACT}">inactive ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov GGO4Y809LO}">METACRESOL</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td></tr><tr><td style="display: none">*</td><td>2.7 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span>/1 mL<span style="background: LightGoldenRodYellow"> (Details: UCUM codemL = 'mL')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="GGO4Y809LO"/>
<display value="METACRESOL"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="2.7"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient3"/>
<resource>
<Ingredient>
<id value="LantusIngredient3"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient3"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient LantusIngredient3</b></p><a name="LantusIngredient3"> </a><a name="hcLantusIngredient3"> </a><a name="LantusIngredient3-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-LantusSolution.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION</a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass IACT}">inactive ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov PDC6A3C0OX}">GLYCERIN</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td></tr><tr><td style="display: none">*</td><td>20 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span>/1 mL<span style="background: LightGoldenRodYellow"> (Details: UCUM codemL = 'mL')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="PDC6A3C0OX"/>
<display value="GLYCERIN"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="20"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient4"/>
<resource>
<Ingredient>
<id value="LantusIngredient4"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient4"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient LantusIngredient4</b></p><a name="LantusIngredient4"> </a><a name="hcLantusIngredient4"> </a><a name="LantusIngredient4-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-LantusSolution.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION</a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass IACT}">inactive ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov 7T1F30V5YH}">POLYSORBATE 20</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td></tr><tr><td style="display: none">*</td><td>20 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM codeug = 'ug')</span>/1 mL<span style="background: LightGoldenRodYellow"> (Details: UCUM codemL = 'mL')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="7T1F30V5YH"/>
<display value="POLYSORBATE 20"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="20"/>
<unit value="ug"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient5"/>
<resource>
<Ingredient>
<id value="LantusIngredient5"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient5"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient LantusIngredient5</b></p><a name="LantusIngredient5"> </a><a name="hcLantusIngredient5"> </a><a name="LantusIngredient5-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-LantusSolution.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION</a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass IACT}">inactive ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov 059QF0KO0R}">WATER</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="059QF0KO0R"/>
<display value="WATER"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient6"/>
<resource>
<Ingredient>
<id value="LantusIngredient6"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient6"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient LantusIngredient6</b></p><a name="LantusIngredient6"> </a><a name="hcLantusIngredient6"> </a><a name="LantusIngredient6-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-LantusSolution.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION</a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass IACT}">inactive ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov QTT17582CB}">HYDROCHLORIC ACID</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="QTT17582CB"/>
<display value="HYDROCHLORIC ACID"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient7"/>
<resource>
<Ingredient>
<id value="LantusIngredient7"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient7"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient LantusIngredient7</b></p><a name="LantusIngredient7"> </a><a name="hcLantusIngredient7"> </a><a name="LantusIngredient7-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-LantusSolution.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION</a></p><p><b>role</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass IACT}">inactive ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov 55X04QC32I}">SODIUM HYDROXIDE</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="55X04QC32I"/>
<display value="SODIUM HYDROXIDE"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/PackagedProductDefinition/LantusVialPackage"/>
<resource>
<PackagedProductDefinition>
<id value="LantusVialPackage"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_LantusVialPackage"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition LantusVialPackage</b></p><a name="LantusVialPackage"> </a><a name="hcLantusVialPackage"> </a><a name="LantusVialPackage-en-US"> </a><p><b>packageFor</b>: <a href="MedicinalProductDefinition-LantusVialDefinition.html">MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0088-5021; route = SUBCUTANEOUS</a></p><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses active}">active</span></td><td>2017-06-04 --> (ongoing)</td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <a href="http://terminology.hl7.org/6.0.2/NamingSystem-v3-ndc.html" title="National drug codes">National drug codes</a>/0088-5021-01</p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C43233}">PACKAGE</span></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C43209}">VIAL, GLASS</span></p><p><b>quantity</b>: 1</p><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes SPLCMBPRDTP}">Combination Product Type</span></td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C112160}">Type 0: Not a Combination Product</span></td></tr></table><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ManufacturedItemDefinition-LantusSolution.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION</a></td></tr></table><p><b>amount</b>: 10 mL<span style="background: LightGoldenRodYellow"> (Details: UCUM codemL = 'mL')</span></p></blockquote></blockquote></blockquote></div>
</text>
<packageFor>🔗
<reference value="MedicinalProductDefinition/LantusVialDefinition"/>
</packageFor>
<marketingStatus>
<status>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses"/>
<code value="active"/>
</coding>
</status>
<dateRange>
<start value="2017-06-04"/>
</dateRange>
</marketingStatus>
<packaging>
<identifier>
<system value="http://hl7.org/fhir/sid/ndc"/>
<value value="0088-5021-01"/>
</identifier>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43233"/>
<display value="PACKAGE"/>
</coding>
</type>
<packaging>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43209"/>
<display value="VIAL, GLASS"/>
</coding>
</type>
<quantity value="1"/>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes"/>
<code value="SPLCMBPRDTP"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C112160"/>
<display value="Type 0: Not a Combination Product"/>
</coding>
</valueCodeableConcept>
</property>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/LantusSolution"/>
</reference>
</item>
<amount>
<value value="10"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/PackagedProductDefinition/LantusSyringePackage"/>
<resource>
<PackagedProductDefinition>
<id value="LantusSyringePackage"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_LantusSyringePackage"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition LantusSyringePackage</b></p><a name="LantusSyringePackage"> </a><a name="hcLantusSyringePackage"> </a><a name="LantusSyringePackage-en-US"> </a><p><b>packageFor</b>: <a href="MedicinalProductDefinition-LantusSyringeDefinition.html">MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0088-5020; route = SUBCUTANEOUS</a></p><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses active}">active</span></td><td>2017-06-04 --> (ongoing)</td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <a href="http://terminology.hl7.org/6.0.2/NamingSystem-v3-ndc.html" title="National drug codes">National drug codes</a>/0088-5020-05</p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C43233}">PACKAGE</span></p><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <a href="http://terminology.hl7.org/6.0.2/NamingSystem-v3-ndc.html" title="National drug codes">National drug codes</a>/0088-5020-01</p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C43202}">SYRINGE</span></p><p><b>quantity</b>: 5</p><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes SPLCMBPRDTP}">Combination Product Type</span></td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C112160}">Type 0: Not a Combination Product</span></td></tr></table><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ManufacturedItemDefinition-LantusSolution.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION</a></td></tr></table><p><b>amount</b>: 3 mL<span style="background: LightGoldenRodYellow"> (Details: UCUM codemL = 'mL')</span></p></blockquote></blockquote></blockquote></div>
</text>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/LantusSyringeDefinition"/>
</packageFor>
<marketingStatus>
<status>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses"/>
<code value="active"/>
</coding>
</status>
<dateRange>
<start value="2017-06-04"/>
</dateRange>
</marketingStatus>
<packaging>
<identifier>
<system value="http://hl7.org/fhir/sid/ndc"/>
<value value="0088-5020-05"/>
</identifier>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43233"/>
<display value="PACKAGE"/>
</coding>
</type>
<packaging>
<identifier>
<system value="http://hl7.org/fhir/sid/ndc"/>
<value value="0088-5020-01"/>
</identifier>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43202"/>
<display value="SYRINGE"/>
</coding>
</type>
<quantity value="5"/>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes"/>
<code value="SPLCMBPRDTP"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C112160"/>
<display value="Type 0: Not a Combination Product"/>
</coding>
</valueCodeableConcept>
</property>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/LantusSolution"/>
</reference>
</item>
<amount>
<value value="3"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/RegulatedAuthorization/LantusVialMarketing"/>
<resource>
<RegulatedAuthorization>
<id value="LantusVialMarketing"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_LantusVialMarketing"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization LantusVialMarketing</b></p><a name="LantusVialMarketing"> </a><a name="hcLantusVialMarketing"> </a><a name="LantusVialMarketing-en-US"> </a><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.3.150</code>/BLA021081</p><p><b>subject</b>: <a href="MedicinalProductDefinition-LantusVialDefinition.html">MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0088-5021; route = SUBCUTANEOUS</a></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C73585}">BLA</span></p><p><b>region</b>: <span title="Codes:{urn:iso:std:iso:3166 USA}">United States of America</span></p></div>
</text>
<identifier>
<system value="urn:oid:2.16.840.1.113883.3.150"/>
<value value="BLA021081"/>
</identifier>
<subject>🔗
<reference value="MedicinalProductDefinition/LantusVialDefinition"/>
</subject>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C73585"/>
<display value="BLA"/>
</coding>
</type>
<region>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="USA"/>
</coding>
</region>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/RegulatedAuthorization/LantusSyringeMarketing"/>
<resource>
<RegulatedAuthorization>
<id value="LantusSyringeMarketing"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_LantusSyringeMarketing"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization LantusSyringeMarketing</b></p><a name="LantusSyringeMarketing"> </a><a name="hcLantusSyringeMarketing"> </a><a name="LantusSyringeMarketing-en-US"> </a><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.3.150</code>/BLA021081</p><p><b>subject</b>: <a href="MedicinalProductDefinition-LantusSyringeDefinition.html">MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0088-5020; route = SUBCUTANEOUS</a></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C73585}">BLA</span></p><p><b>region</b>: <span title="Codes:{urn:iso:std:iso:3166 USA}">United States of America</span></p></div>
</text>
<identifier>
<system value="urn:oid:2.16.840.1.113883.3.150"/>
<value value="BLA021081"/>
</identifier>
<subject>🔗
<reference
value="MedicinalProductDefinition/LantusSyringeDefinition"/>
</subject>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C73585"/>
<display value="BLA"/>
</coding>
</type>
<region>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="USA"/>
</coding>
</region>
</RegulatedAuthorization>
</resource>
</entry>
</Bundle>
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.2.1 based on FHIR 5.0.0. Generated 2024-10-26
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