Entacapone
Entacapone Tablets, USP Rx only Prescribing Information
Approved
Approval ID
d9cc1327-5474-4136-970a-ec40c41975b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 21, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code65862-654
Application NumberANDA203437
Product Classification
M
Marketing Category
C73584
G
Generic Name
Entacapone
Product Specifications
Route of AdministrationORAL
Effective DateJune 21, 2023
FDA Product Classification
INGREDIENTS (15)
ENTACAPONEActive
Quantity: 200 mg in 1 1
Code: 4975G9NM6T
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT