Codeine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2015-09-01)
Oldest Current Product
2009-07-15
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\CODEINE
FDAOB
ORAL\TABLET\CODEINE SULFATE
SPL Active
ORAL\TABLET\CODEINE SULFATE
SPL Moiety
ORAL\TABLET\CODEINE
ORAL\TABLET\CODEINE ANHYDROUS

product(s) by strength(s)

codeine sulfate 15 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540243NDARoxane Laboratories, Inc2009-07-16CODEINE SULFATEORALTABLETNDA022402fa3ed180-298a-4f9d-9d05-15182d7218bf

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271727ANDALannett Company, Inc.2014-06-13CODEINE SULFATEORALTABLETANDA2030465819bdf7-300e-45b8-8f3a-447b53656293

codeine sulfate 30 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540244NDARoxane Laboratories, Inc2009-07-16CODEINE SULFATEORALTABLETNDA022402fa3ed180-298a-4f9d-9d05-15182d7218bf

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271698ANDALannett Company, Inc.2014-06-13CODEINE SULFATEORALTABLETANDA2030465819bdf7-300e-45b8-8f3a-447b53656293

codeine sulfate 60 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540245NDARoxane Laboratories, Inc2009-07-16CODEINE SULFATEORALTABLETNDA022402fa3ed180-298a-4f9d-9d05-15182d7218bf

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271699ANDALannett Company, Inc.2014-06-13CODEINE SULFATEORALTABLETANDA2030465819bdf7-300e-45b8-8f3a-447b53656293

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548682541NDAPhysicians Total Care, Inc.2009-07-15CODEINE SULFATEORALTABLET000544157NDA022402f317cd06-2851-4a52-86d3-6efde3a4c243

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA203046CODEINE SULFATELANNETT HOLDINGS INC2014-06-13ANDA203046_001, ANDA203046_002, ANDA203046_003
2NDA022402CODEINE SULFATEROXANE LABORATORIES INC2009-07-16NDA022402_001, NDA022402_002, NDA022402_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA203046_001RXCODEINE SULFATE (15MG)ORALTABLETFalseAB2014-06-13CODEINE SULFATE
2ANDA203046_002RXCODEINE SULFATE (30MG)ORALTABLETFalseAB2014-06-13CODEINE SULFATE
3ANDA203046_003RXCODEINE SULFATE (60MG)ORALTABLETFalseAB2014-06-13CODEINE SULFATE
4NDA022402_001RXCODEINE SULFATE (15MG)ORALTABLETFalseAB2009-07-16CODEINE SULFATE
5NDA022402_002RXCODEINE SULFATE (30MG)ORALTABLETFalseAB2009-07-16CODEINE SULFATE
6NDA022402_003RXCODEINE SULFATE (60MG)ORALTABLETTrueAB2009-07-16CODEINE SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15819bdf7-300e-45b8-8f3a-447b53656293 (view SPL)These highlights do not include all the information needed to use codeine sulfate tablets safely and effectively. See full prescribing information for codeine sulfate tablets. CODEINEsulfate tablets, USP,for oral useCIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-06-176005271698, 005271699, 005271727
2f317cd06-2851-4a52-86d3-6efde3a4c243 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-10-221548682541
3fa3ed180-298a-4f9d-9d05-15182d7218bf (view SPL)These highlights do not include all the information needed to use CODEINE sulfate tablets, USP safely and effectively. See full prescribing information for CODEINE sulfate tablets, USP. CODEINE sulfate tablets, USP for oral use, CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-09-0112000540243, 000540244, 000540245

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII