Entacapone
Entacapone Tablets Rx only Prescribing Information
Approved
Approval ID
3b19e8e3-336c-4aef-8721-ed121e216155
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 24, 2020
Manufacturers
FDA
Wockhardt USA LLC.
DUNS: 170508365
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 Code64679-781
Application NumberNDA020796
Product Classification
M
Marketing Category
C73594
G
Generic Name
Entacapone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 24, 2020
FDA Product Classification
INGREDIENTS (13)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ENTACAPONEActive
Quantity: 200 mg in 1 1
Code: 4975G9NM6T
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT