ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP(300 mg/15 mg, 300 mg/30 mg, 300 mg/60 mg) CIII Rx only
Approved
Approval ID
3b455938-7bbc-4626-939b-40b37709befb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49999-060
Application NumberANDA040419
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2022
FDA Product Classification
INGREDIENTS (8)
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CODEINE PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT