HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Hydrocodone Bitartrate & Acetaminophen Tablets
Approved
Approval ID
c7a9280e-e713-4773-b4bd-aabec9cff63a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 2, 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 bitartrate and acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-0515
Application NumberANDA040655
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocodone bitartrate and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2011
FDA Product Classification
INGREDIENTS (13)
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT