Hydrocodone Acetaminophen
Hydrocodone Bitartrate & Acetaminophen
Approved
Approval ID
b165dffd-1550-4d8d-a8ea-fe83512c34e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 24, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYDROCODONE, ACETAMINOPHEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-0016
Application NumberANDA081083
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCODONE, ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2011
FDA Product Classification
INGREDIENTS (13)
MAGNESIUMInactive
Code: I38ZP9992A
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 750 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT