Entacapone
Entacapone Tablets
Approved
Approval ID
f34a7de7-488c-4543-9518-2abe8e651c88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 10, 2013
Manufacturers
FDA
Wockhardt Limited
DUNS: 650069115
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Entacapone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55648-290
Application NumberNDA020796
Product Classification
M
Marketing Category
C73605
G
Generic Name
Entacapone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 10, 2013
FDA Product Classification
INGREDIENTS (13)
ENTACAPONEActive
Quantity: 200 mg in 1 1
Code: 4975G9NM6T
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT