Entacapone
Rx Only
Approved
Approval ID
56327e32-3b06-4144-91a0-bb1908842e33
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
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 Code33342-260
Application NumberANDA207210
Product Classification
M
Marketing Category
C73584
G
Generic Name
Entacapone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (12)
ENTACAPONEActive
Quantity: 200 mg in 1 1
Code: 4975G9NM6T
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT