Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine Phosphate Tablets, USP CIII
Approved
Approval ID
6286e128-1288-4dc0-b14b-f04a0e2a22f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 10, 2019
Manufacturers
FDA
Elite Laboratories, Inc.
DUNS: 785398728
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen and Codeine Phosphate
PRODUCT DETAILS
NDC Product Code64850-643
Application NumberANDA212418
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 17, 2019
Generic NameAcetaminophen and Codeine Phosphate
INGREDIENTS (5)
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CODEINE PHOSPHATEActive
Quantity: 60 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Acetaminophen and Codeine Phosphate
PRODUCT DETAILS
NDC Product Code64850-642
Application NumberANDA212418
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 17, 2019
Generic NameAcetaminophen and Codeine Phosphate
INGREDIENTS (5)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CODEINE PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
Acetaminophen and Codeine Phosphate
PRODUCT DETAILS
NDC Product Code64850-641
Application NumberANDA212418
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 17, 2019
Generic NameAcetaminophen and Codeine Phosphate
INGREDIENTS (5)
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CODEINE PHOSPHATEActive
Quantity: 15 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT