Draft PH Core Implementation Guide, published by UP Manila National TeleHealth Center. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/UP-Manila-SILab/ph-core/ and changes regularly. See the Directory of published versions

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: PH FDA Certificate of Product Registration (CPR) CodeSystem - XML Representation

Active as of 2026-03-21

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="PHFDACPRCS"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem PHFDACPRCS</b></p><a name="PHFDACPRCS"> </a><a name="hcPHFDACPRCS"> </a><p><b>Properties</b></p><p><b>This code system defines the following properties for its concepts</b></p><table class="grid"><tr><td><b>Name</b></td><td><b>Code</b></td><td><b>Type</b></td><td><b>Description</b></td></tr><tr><td>productInfo</td><td>productInfo</td><td>string</td><td>Product information document</td></tr><tr><td>genericName</td><td>genericName</td><td>string</td><td>Generic/INN name of the drug</td></tr><tr><td>dosageStrength</td><td>dosageStrength</td><td>string</td><td>Dosage strength/concentration</td></tr><tr><td>dosageForm</td><td>dosageForm</td><td>string</td><td>Dosage form (e.g., Tablet, Injection)</td></tr><tr><td>classification</td><td>classification</td><td>string</td><td>Drug classification (RX, OTC, etc.)</td></tr><tr><td>packaging</td><td>packaging</td><td>string</td><td>Packaging description</td></tr><tr><td>pharmacologicCategory</td><td>pharmacologicCategory</td><td>string</td><td>Pharmacologic/therapeutic category</td></tr><tr><td>manufacturer</td><td>manufacturer</td><td>string</td><td>Drug manufacturer</td></tr><tr><td>countryOfOrigin</td><td>countryOfOrigin</td><td>string</td><td>Country where manufactured</td></tr><tr><td>trader</td><td>trader</td><td>string</td><td>Trading company</td></tr><tr><td>importer</td><td>importer</td><td>string</td><td>Importing company</td></tr><tr><td>distributor</td><td>distributor</td><td>string</td><td>Distributing company</td></tr><tr><td>applicationType</td><td>applicationType</td><td>string</td><td>Type of FDA application</td></tr><tr><td>issuanceDate</td><td>issuanceDate</td><td>string</td><td>Registration issuance date</td></tr><tr><td>expiryDate</td><td>expiryDate</td><td>string</td><td>Registration expiry date</td></tr></table><p><b>Concepts</b></p><p>This case-insensitive code system <code>https://verification.fda.gov.ph/</code> provides <b>a fragment</b> that includes following codes in a Is-A hierarchy:</p><table class="codes"><tr><td><b>Lvl</b></td><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td><td><b>genericName</b></td><td><b>dosageStrength</b></td><td><b>dosageForm</b></td><td><b>classification</b></td><td><b>packaging</b></td><td><b>pharmacologicCategory</b></td><td><b>manufacturer</b></td><td><b>countryOfOrigin</b></td><td><b>importer</b></td><td><b>distributor</b></td><td><b>applicationType</b></td><td><b>issuanceDate</b></td><td><b>expiryDate</b></td></tr><tr><td>1</td><td style="white-space:nowrap">PH-FDA-DRUGS<a name="PHFDACPRCS-PH-FDA-DRUGS"> </a></td><td>Philippine FDA Registered Drug Products</td><td>Root concept for all FDA Certificate of Product Registration (CPR) registered medications in the Philippines</td><td/><td/><td/><td/><td/><td/><td/><td/><td/><td/><td/><td/><td/></tr><tr><td>2</td><td style="white-space:nowrap">  DRP-10144<a name="PHFDACPRCS-DRP-10144"> </a></td><td>Twinact</td><td/><td>Telmisartan + Amlodipine (as besilate)</td><td>40 mg 5 mg</td><td>Tablet</td><td>Prescription Drug (RX)</td><td>Alu/Alu blister pack x 10's (Box of 30's)</td><td>-</td><td>Dasan Pharmaceutical Co., Ltd.</td><td>Korea</td><td>Unilab, Inc.</td><td>Unilab, Inc.</td><td>Initial (Reconstruction)</td><td>16 January 2024</td><td>30 July 2026</td></tr><tr><td>2</td><td style="white-space:nowrap">  1193768<a name="PHFDACPRCS-1193768"> </a></td><td>Ascorfed-Z Cap</td><td/><td>Ascorbic Acid + Zinc</td><td>500 mg (equivalent to 562.5 mg Sodium Ascorbate)/10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)</td><td>Capsule</td><td>Over-the-Counter (OTC) Drug</td><td>Alu/Deep Red PVC Blister Pack x 10's / (Box of 30's and 100's)</td><td>Vitamin/Mineral</td><td/><td/><td/><td/><td/><td/><td/></tr></table></div>
  </text>
  <url value="https://verification.fda.gov.ph/"/>
  <version value="0.1.0"/>
  <name value="PHFDACPRCS"/>
  <title value="PH FDA Certificate of Product Registration (CPR) CodeSystem"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-03-21"/>
  <publisher value="UP Manila National TeleHealth Center"/>
  <contact>
    <name value="UP Manila National TeleHealth Center"/>
    <telecom>
      <system value="url"/>
      <value value="https://github.com/UP-NTHC"/>
    </telecom>
  </contact>
  <description
               value="Registered drug products from the Philippine Food and Drug Administration (FDA)"/>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="PH"/>
      <display value="Philippines"/>
    </coding>
  </jurisdiction>
  <caseSensitive value="false"/>
  <hierarchyMeaning value="is-a"/>
  <content value="fragment"/>
  <property>
    <code value="productInfo"/>
    <description value="Product information document"/>
    <type value="string"/>
  </property>
  <property>
    <code value="genericName"/>
    <description value="Generic/INN name of the drug"/>
    <type value="string"/>
  </property>
  <property>
    <code value="dosageStrength"/>
    <description value="Dosage strength/concentration"/>
    <type value="string"/>
  </property>
  <property>
    <code value="dosageForm"/>
    <description value="Dosage form (e.g., Tablet, Injection)"/>
    <type value="string"/>
  </property>
  <property>
    <code value="classification"/>
    <description value="Drug classification (RX, OTC, etc.)"/>
    <type value="string"/>
  </property>
  <property>
    <code value="packaging"/>
    <description value="Packaging description"/>
    <type value="string"/>
  </property>
  <property>
    <code value="pharmacologicCategory"/>
    <description value="Pharmacologic/therapeutic category"/>
    <type value="string"/>
  </property>
  <property>
    <code value="manufacturer"/>
    <description value="Drug manufacturer"/>
    <type value="string"/>
  </property>
  <property>
    <code value="countryOfOrigin"/>
    <description value="Country where manufactured"/>
    <type value="string"/>
  </property>
  <property>
    <code value="trader"/>
    <description value="Trading company"/>
    <type value="string"/>
  </property>
  <property>
    <code value="importer"/>
    <description value="Importing company"/>
    <type value="string"/>
  </property>
  <property>
    <code value="distributor"/>
    <description value="Distributing company"/>
    <type value="string"/>
  </property>
  <property>
    <code value="applicationType"/>
    <description value="Type of FDA application"/>
    <type value="string"/>
  </property>
  <property>
    <code value="issuanceDate"/>
    <description value="Registration issuance date"/>
    <type value="string"/>
  </property>
  <property>
    <code value="expiryDate"/>
    <description value="Registration expiry date"/>
    <type value="string"/>
  </property>
  <concept>
    <code value="PH-FDA-DRUGS"/>
    <display value="Philippine FDA Registered Drug Products"/>
    <definition
                value="Root concept for all FDA Certificate of Product Registration (CPR) registered medications in the Philippines"/>
    <concept>
      <code value="DRP-10144"/>
      <display value="Twinact"/>
      <property>
        <code value="genericName"/>
        <valueString value="Telmisartan + Amlodipine (as besilate)"/>
      </property>
      <property>
        <code value="dosageStrength"/>
        <valueString value="40 mg 5 mg"/>
      </property>
      <property>
        <code value="dosageForm"/>
        <valueString value="Tablet"/>
      </property>
      <property>
        <code value="classification"/>
        <valueString value="Prescription Drug (RX)"/>
      </property>
      <property>
        <code value="packaging"/>
        <valueString value="Alu/Alu blister pack x 10's (Box of 30's)"/>
      </property>
      <property>
        <code value="pharmacologicCategory"/>
        <valueString value="-"/>
      </property>
      <property>
        <code value="manufacturer"/>
        <valueString value="Dasan Pharmaceutical Co., Ltd."/>
      </property>
      <property>
        <code value="countryOfOrigin"/>
        <valueString value="Korea"/>
      </property>
      <property>
        <code value="importer"/>
        <valueString value="Unilab, Inc."/>
      </property>
      <property>
        <code value="distributor"/>
        <valueString value="Unilab, Inc."/>
      </property>
      <property>
        <code value="applicationType"/>
        <valueString value="Initial (Reconstruction)"/>
      </property>
      <property>
        <code value="issuanceDate"/>
        <valueString value="16 January 2024"/>
      </property>
      <property>
        <code value="expiryDate"/>
        <valueString value="30 July 2026"/>
      </property>
    </concept>
    <concept>
      <code value="1193768"/>
      <display value="Ascorfed-Z Cap"/>
      <property>
        <code value="genericName"/>
        <valueString value="Ascorbic Acid + Zinc"/>
      </property>
      <property>
        <code value="dosageStrength"/>
        <valueString
                     value="500 mg (equivalent to 562.5 mg Sodium Ascorbate)/10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)"/>
      </property>
      <property>
        <code value="dosageForm"/>
        <valueString value="Capsule"/>
      </property>
      <property>
        <code value="classification"/>
        <valueString value="Over-the-Counter (OTC) Drug"/>
      </property>
      <property>
        <code value="packaging"/>
        <valueString
                     value="Alu/Deep Red PVC Blister Pack x 10's / (Box of 30's and 100's)"/>
      </property>
      <property>
        <code value="pharmacologicCategory"/>
        <valueString value="Vitamin/Mineral"/>
      </property>
    </concept>
  </concept>
</CodeSystem>