Vicoprofen
VICOPROFEN®(hydrocodone bitartrate and ibuprofen tablets)7.5 mg/200 mgCS-III
Approved
Approval ID
f914699b-12a7-44f1-846f-e6437a16e35d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 12, 2011
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 Bitartrate and Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4035
Application NumberNDA020716
Product Classification
M
Marketing Category
C73594
G
Generic Name
Hydrocodone Bitartrate and Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2011
FDA Product Classification
INGREDIENTS (12)
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
IBUPROFENActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT