HYDROCODONE BITARTRATE AND ACETAMINOPHEN
hydrocodone bitartrate and acetaminophen tablet
Approved
Approval ID
0af451fc-67e6-454b-88e7-ab5746f6dbb5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2010
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
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 Code68387-230
Application NumberANDA089699
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2010
FDA Product Classification
INGREDIENTS (10)
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 500 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
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT