Norco
NORCO 7-5 mg_325 mg and 10 mg_325 mg
Approved
Approval ID
44b86290-2391-4b02-abd4-b1c0c611891e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 2, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Bitatrate and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4034
Application NumberANDA040148
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitatrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateMay 2, 2012
FDA Product Classification
INGREDIENTS (11)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 10 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT