 0 Table of Contents |
  1 SPL Mapping Implementation Guide Home Page |
  2 Organziation-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 EstablishmentRegistrant |
   8.163 All NDC Products |
   8.164 Business Operation Qualifiers |
   8.165 Establishment Business Operations |
   8.166 GDUFA Facility Business Operation Qualifiers |
   8.167 GDUFA Facility Business Operations |
   8.168 Generic Facility Message Types |
   8.169 Labeler Business Operations |
   8.170 Organzation Submission Message Types |
   8.171 Registrant Organization Types |
   8.172 SPL Document Codes |
   8.173 SPL Marketing Statuses ValueSet |
   8.174 SPL Product Characteristic Types ValueSet |
   8.175 SPL Section Codes |
   8.176 Top-Level Organization Types |
   8.177 FHIR Specific SPL Message Types |
   8.178 Medicinal Product Name Types CodeSystem |
   8.179 Organization Relationship Types |
   8.180 SPL Marketing Statuses CodeSystem |
   8.181 SPL Organization Types |
   8.182 SPL Product Characteristic Types CodeSystem |
   8.183 EnbrelKit |
   8.184 ExampleEstablishment |
   8.185 ExampleEstablishmentAffiliation |
   8.186 ExampleEstablishmentFHIRtoSPLProvenance |
   8.187 ExampleEstablishmentOperation |
   8.188 ExampleEstablishmentRegistrant |
   8.189 ExampleEstablishmentRegistration |
   8.190 ExampleEstablishmentSPLtoFHIRProvenance |
   8.191 ExampleGDUFAFacility |
   8.192 ExampleGDUFAFacilityAffiliation |
   8.193 ExampleGDUFAFacilityIdentification |
   8.194 ExampleGDUFAFacilityInactivation |
   8.195 ExampleGDUFAFacilityOperation |
   8.196 ExampleGDUFARegistrant |
   8.197 ExampleImporter |
   8.198 ExampleImporterAffiliation |
   8.199 ExampleLabelerFHIRtoSPLProvenance |
   8.200 ExampleLabelerSPLtoFHIRProvenance |
   8.201 ExampleSPLDocumentReference |
   8.202 IdentifiedLabelerOrganization |
   8.203 SampleEstablishmentInactivationBundle |
   8.204 SampleEstablishmentInactivationMessage |
   8.205 SampleEstablishmentRegistrationMessage |
   8.206 SampleGDUFAFacilityIdentificationMessage |
   8.207 SampleGDUFAFacilityInactivationMessage |
   8.208 SampleIdentifiedEstablishment |
   8.209 SampleIdentifiedEstablishmentRegistrant |
   8.210 SampleIdentifiedGDUFAFacility |
   8.211 SampleIdentifiedGDUFARegistrant |
   8.212 SampleLabelerBusinessOperation |
   8.213 SampleLabelerCodeRequestBundle |
   8.214 SampleLabelerCodeRequestMessage |
   8.215 SampleLabelerInactivationBundle |
   8.216 SampleLabelerInactivationMessage |
   8.217 SampleLabelerOrganization |
   8.218 SampleLabelerUSAgent |
   8.219 SampleLabelerUSAgentAffiliation |
   8.220 SampleOutOfBusinessNotificationBundle |
   8.221 SamplOutOfBusinessMessage |