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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64850-643
Application NumberANDA212418
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2019
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64850-642
Application NumberANDA212418
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2019
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64850-641
Application NumberANDA212418
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2019
FDA Product Classification
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