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NDC 65862-0654-99 Entacapone 200 mg/1 Details

Entacapone 200 mg/1

Entacapone is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is ENTACAPONE.

MedlinePlus Drug Summary

Entacapone is an inhibitor of catechol-O-methyltransferase (COMT). It is used in combination with levodopa and carbidopa (Sinemet) to treat the end-of-dose 'wearing-off' symptoms of Parkinson's disease. Entacapone helps the levodopa and carbidopa work better by allowing more of it to reach the brain, where it has its effects. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 65862-0654-99
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Entacapone

Product Information

NDC	65862-0654
Product ID	65862-654_990534c8-16b2-451d-bf61-7ec91ceac88d
Associated GPIs	73153030000320
GCN Sequence Number	041199
GCN Sequence Number Description	entacapone TABLET 200 MG ORAL
HIC3	H6A
HIC3 Description	ANTIPARKINSONISM DRUGS,OTHER
GCN	95079
HICL Sequence Number	018950
HICL Sequence Number Description	ENTACAPONE
Brand/Generic	Generic
Proprietary Name	Entacapone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Entacapone
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	ENTACAPONE
Labeler Name	Aurobindo Pharma Limited
Pharmaceutical Class	Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA203437
Listing Certified Through	2024-12-31

Package

NDC 65862-0654-99 (65862065499)

Pricing Information	N/A
NDC Package Code	65862-654-99
Billing NDC	65862065499
Package	1000 TABLET, FILM COATED in 1 BOTTLE (65862-654-99)
Marketing Start Date	2015-06-19
NDC Exclude Flag	N