ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine Phosphate Tablets USP CIII
Approved
Approval ID
9ca1321e-380a-48d7-8a58-c6501858c1c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2024
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
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 Code50090-3011
Application NumberANDA040419
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 28, 2023
Generic Nameacetaminophen and codeine phosphate
INGREDIENTS (8)
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CODEINE PHOSPHATEActive
Quantity: 60 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT