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
403f109d-618d-404d-9ce6-11192e6e1796
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2011
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
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 Code10544-032
Application NumberANDA040419
Product Classification
M
Marketing Category
C73584
G
Generic Name
acetaminophen and codeine phosphate
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2011
FDA Product Classification
INGREDIENTS (8)
CODEINE PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT