Codeine sulfate
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. CODEINE SULFATE tablets, for oral use CIIInitial U.S. Approval: 1950
Approved
Approval ID
010905f9-3bcb-4b50-9fe8-a3ad0010f14c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
codeine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0244
Application NumberNDA022402
Product Classification
M
Marketing Category
C73594
G
Generic Name
codeine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2021
FDA Product Classification
INGREDIENTS (5)
CODEINE SULFATEActive
Quantity: 30 mg in 1 1
Code: 11QV9BS0CB
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
codeine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0245
Application NumberNDA022402
Product Classification
M
Marketing Category
C73594
G
Generic Name
codeine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2021
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CODEINE SULFATEActive
Quantity: 60 mg in 1 1
Code: 11QV9BS0CB
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
codeine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0243
Application NumberNDA022402
Product Classification
M
Marketing Category
C73594
G
Generic Name
codeine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2021
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CODEINE SULFATEActive
Quantity: 15 mg in 1 1
Code: 11QV9BS0CB
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT