Acetaminophen And Codeine
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP300 mg/30 mg and 300 mg/60 mg
Approved
Approval ID
f94eb4bf-c577-4fa3-bfba-a12a6b821174
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 9, 2010
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
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 Code68387-250
Application NumberANDA089805
Product Classification
M
Marketing Category
C73584
G
Generic Name
acetaminophen and codeine phosphate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2010
FDA Product Classification
INGREDIENTS (9)
CODEINE PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT