Acetaminophen and Codeine
Acetaminophen and Codeine Phosphate Tablets, USP 300mg/30mg
Approved
Approval ID
894b2958-a67f-42bc-9b49-ba5400811695
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 5, 2014
Manufacturers
FDA
RxChange Co.
DUNS: 781126805
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen and Codeine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33358-001
Application NumberANDA040779
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2014
FDA Product Classification
INGREDIENTS (10)
CODEINE PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT