Norco
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
Approved
Approval ID
566bd196-3c0c-4f05-9e2e-4803ad3126d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 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 Code68387-236
Application NumberANDA040099
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate And Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2010
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT