Acetaminophen and Codeine
Approved
Approval ID
fdea5078-b6d3-4c2b-981b-398bb1fadc40
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2013
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 Code10544-100
Application NumberANDA089805
Product Classification
M
Marketing Category
C73584
G
Generic Name
acetaminophen and codeine phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2013
FDA Product Classification
INGREDIENTS (9)
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CODEINE PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT