ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine Phosphate Tablets USP CIII
Approved
Approval ID
e42fa7d2-47f0-0e82-e053-2995a90a67c5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2022
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-2800
Application NumberANDA040419
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 19, 2022
Generic Nameacetaminophen and codeine phosphate
INGREDIENTS (8)
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
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CODEINE PHOSPHATEActive
Quantity: 60 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB