0 Table of Contents |
1 SPL Mapping Implementation Guide Home Page |
2 Organization-Based Use Cases |
3 Submit a Drug Label |
4 How to Create a FHIR Drug Label |
5 SPL / FHIR Transforms |
6 Downloads |
7 Credits |
8 Artifacts Summary |
8.1 Establishment Registration Logical Model |
8.2 GDUFA Facility Identification Logical Model |
8.3 NDC Labeler Code Request Logical Model |
8.4 Product Submission Document Logical Model |
8.5 Submitted Medication Logical Model |
8.6 EstablishmentInactivationBundle |
8.7 EstablishmentRegistrationBundle |
8.8 GDUFAFacilityIdentificationBundle |
8.9 GDUFAFacilityInactivationBundle |
8.10 LabelerCodeRequestBundle |
8.11 LabelerInactivationBundle |
8.12 OrganizationBundle |
8.13 OutOfBusinessBundle |
8.14 EstablishmentInactivationMessage |
8.15 EstablishmentRegistrationMessage |
8.16 GDUFAFacilityIdentificationMessage |
8.17 GDUFAFacilityInactivationMessage |
8.18 LabelerCodeRequestMessage |
8.19 LabelerInactivationMessage |
8.20 OrganizationMessage |
8.21 OutOfBusinessMessage |
8.22 IdentifiedLabeler |
8.23 LabelerBusinessOperation |
8.24 LabelerOrganization |
8.25 EstablishmentAffiliation |
8.26 EstablishmentBusinessOperation |
8.27 EstablishmentOrganization |
8.28 EstablishmentRegistrantOrganization |
8.29 IdentifiedEstablishment |
8.30 IdentifiedEstablishmentRegistrant |
8.31 GDUFAFacilityAffiliation |
8.32 GDUFAFacilityBusinessOperation |
8.33 GDUFAFacilityOrganization |
8.34 GDUFARegistrantOrganization |
8.35 IdentifiedGDUFAFacility |
8.36 IdentifiedGDUFARegistrant |
8.37 IdentifiedOrganization |
8.38 ImporterAffiliation |
8.39 ImporterOrganization |
8.40 RegistrantOrganization |
8.41 SPLAddress |
8.42 SPLContactPoint |
8.43 USAgentAffiliation |
8.44 USAgentOrganization |
8.45 Manufactured Item Marketing Status Date Range |
8.46 Packaged Product Reference |
8.47 ProductSubmissionBundle |
8.48 ProductSubmissionDocument |
8.49 SectionEffectiveTime |
8.50 SectionLinkId |
8.51 SubmittedIngredientDefinition |
8.52 SubmittedManufacturedItem |
8.53 SubmittedMedicinalPackaging |
8.54 SubmittedMedicinalProduct |
8.55 SubmittedMedicinalProductIngredient |
8.56 SubmittedMedicinalProductMarketing |
8.57 VersionNumber |
8.58 DualSubmissionProvenance |
8.59 SPLDocumentDate |
8.60 SPLDocumentReference |
8.61 AidarexPharmaceuticals |
8.62 Allopurinol100Tablets |
8.63 Allopurinol30Tablets |
8.64 Allopurinol60Tablets |
8.65 Allopurinol90Tablets |
8.66 Allopurinol<br/>Tablets USP<br/>Revised: February 2015<br/>Rx only <br/> |
8.67 AllopurinolIngredientDefinition |
8.68 AllopurinolMarketing |
8.69 AllopurinolTablet |
8.70 AllopurinolTabletLabelBundle |
8.71 AllopurinolUSPActiveIngredient |
8.72 AllopurinolUSPDefinition |
8.73 AllopurinolUSPIngredient1 |
8.74 AllopurinolUSPIngredient2 |
8.75 AllopurinolUSPIngredient3 |
8.76 AllopurinolUSPIngredient4 |
8.77 AllopurinolUSPIngredient5 |
8.78 AllopurinolUSPIngredient6 |
8.79 Enbrel010Definition |
8.80 Enbrel010Marketing |
8.81 Enbrel010Package |
8.82 Enbrel021Definition |
8.83 Enbrel021Marketing |
8.84 Enbrel021Package |
8.85 Enbrel032Definition |
8.86 Enbrel032Marketing |
8.87 Enbrel032Package |
8.88 Enbrel044Definition |
8.89 Enbrel044Marketing |
8.90 Enbrel044Package |
8.91 Enbrel055Definition |
8.92 Enbrel055Marketing |
8.93 Enbrel055Package |
8.94 Enbrel25mgSolution |
8.95 Enbrel25mgSolutionActiveIngredient |
8.96 Enbrel25mgSolutionIngredient1 |
8.97 Enbrel25mgSolutionIngredient2 |
8.98 Enbrel25mgSolutionIngredient3 |
8.99 Enbrel425Definition |
8.100 Enbrel425Marketing |
8.101 Enbrel425Package |
8.102 Enbrel425Part1Definition |
8.103 Enbrel425Part1Marketing |
8.104 Enbrel425Part1Package |
8.105 Enbrel425Part2Definition |
8.106 Enbrel425Part2Marketing |
8.107 Enbrel425Part2Package |
8.108 Enbrel435Definition |
8.109 Enbrel435Marketing |
8.110 Enbrel435Package |
8.111 Enbrel445Definition |
8.112 Enbrel445Marketing |
8.113 Enbrel445Package |
8.114 Enbrel446Definition |
8.115 Enbrel446Marketing |
8.116 Enbrel446Package |
8.117 Enbrel455Definition |
8.118 Enbrel455Marketing |
8.119 Enbrel455Package |
8.120 Enbrel456Definition |
8.121 Enbrel456Marketing |
8.122 Enbrel456Package |
8.123 Enbrel50mgSolution |
8.124 Enbrel50mgSolutionActiveIngredient |
8.125 Enbrel50mgSolutionIngredient1 |
8.126 Enbrel50mgSolutionIngredient2 |
8.127 Enbrel50mgSolutionIngredient3 |
8.128 EnbrelIngredientDefinition |
8.129 EnbrelPowder |
8.130 EnbrelPowderActiveIngredient |
8.131 EnbrelPowderIngredient1 |
8.132 EnbrelPowderIngredient2 |
8.133 EnbrelPowderIngredient3 |
8.134 EnbrelSterileSolution |
8.135 EnbrelSterileSolutionIngredient1 |
8.136 EnbrelSterileSolutionIngredient2 |
8.137 EnbrelSyringeLabelBundle |
8.138 ImmunexCorporation |
8.139 These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. <br/>
<br/>ENBREL<sup>®</sup> (etanercept) injection, for subcutaneous use <br/>ENBREL<sup>®</sup> (etanercept) for injection, for subcutaneous use <br/>Initial U.S. Approval: 1998 |
8.140 LantusActiveIngredient |
8.141 LantusIngredient1 |
8.142 LantusIngredient2 |
8.143 LantusIngredient3 |
8.144 LantusIngredient4 |
8.145 LantusIngredient5 |
8.146 LantusIngredient6 |
8.147 LantusIngredient7 |
8.148 LantusIngredientDefinition |
8.149 LantusInjectionLabelBundle |
8.150 LantusSolution |
8.151 LantusSyringeDefinition |
8.152 LantusSyringeMarketing |
8.153 LantusSyringePackage |
8.154 LantusVialDefinition |
8.155 LantusVialMarketing |
8.156 LantusVialPackage |
8.157 SanofiAventisDeutschland |
8.158 SanofiAventisSRL |
8.159 SanofiAventisUS |
8.160 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 |
8.161 ProvenanceActivitySearchParameter |
8.162 All NDC Products |
8.163 Business Operation Qualifiers |
8.164 Establishment Business Operations |
8.165 GDUFA Facility Business Operation Qualifiers |
8.166 GDUFA Facility Business Operations |
8.167 Generic Facility Message Types |
8.168 Labeler Business Operations |
8.169 Organization Submission Message Types |
8.170 Registrant Organization Types |
8.171 SPL Color |
8.172 SPL Combo Product Type |
8.173 SPL Document Codes |
8.174 SPL Dose Form |
8.175 SPL Flavor |
8.176 SPL Marketing Categories |
8.177 SPL Marketing Statuses ValueSet |
8.178 SPL Operation Type |
8.179 SPL Package Types |
8.180 SPL Product Characteristic Types ValueSet |
8.181 SPL Route of Administration |
8.182 SPL Section Codes |
8.183 SPL Shape |
8.184 SPL Special Measures |
8.185 Top-Level Organization Types |
8.186 FHIR Specific SPL Message Types |
8.187 Medicinal Product Name Types CodeSystem |
8.188 Organization Relationship Types |
8.189 SPL Marketing Statuses CodeSystem |
8.190 SPL Organization Types |
8.191 SPL Product Characteristic Types CodeSystem |
8.192 EnbrelKit |
8.193 ExampleEstablishment |
8.194 ExampleEstablishmentAffiliation |
8.195 ExampleEstablishmentFHIRtoSPLProvenance |
8.196 ExampleEstablishmentOperation |
8.197 ExampleEstablishmentRegistrant |
8.198 ExampleEstablishmentRegistration |
8.199 ExampleEstablishmentSPLtoFHIRProvenance |
8.200 ExampleGDUFAFacility |
8.201 ExampleGDUFAFacilityAffiliation |
8.202 ExampleGDUFAFacilityIdentification |
8.203 ExampleGDUFAFacilityInactivation |
8.204 ExampleGDUFAFacilityOperation |
8.205 ExampleGDUFARegistrant |
8.206 ExampleImporter |
8.207 ExampleImporterAffiliation |
8.208 ExampleLabelerFHIRtoSPLProvenance |
8.209 ExampleLabelerSPLtoFHIRProvenance |
8.210 ExampleSPLDocumentReference |
8.211 IdentifiedLabelerOrganization |
8.212 SampleEstablishmentInactivationBundle |
8.213 SampleEstablishmentInactivationMessage |
8.214 SampleEstablishmentRegistrationMessage |
8.215 SampleGDUFAFacilityIdentificationMessage |
8.216 SampleGDUFAFacilityInactivationMessage |
8.217 SampleIdentifiedEstablishment |
8.218 SampleIdentifiedEstablishmentRegistrant |
8.219 SampleIdentifiedGDUFAFacility |
8.220 SampleIdentifiedGDUFARegistrant |
8.221 SampleLabelerBusinessOperation |
8.222 SampleLabelerCodeRequestBundle |
8.223 SampleLabelerCodeRequestMessage |
8.224 SampleLabelerInactivationBundle |
8.225 SampleLabelerInactivationMessage |
8.226 SampleLabelerOrganization |
8.227 SampleLabelerUSAgent |
8.228 SampleLabelerUSAgentAffiliation |
8.229 SampleOutOfBusinessNotificationBundle |
8.230 SamplOutOfBusinessMessage |