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Active ingredient

Entacapone

14 finished FDA listings contain Entacapone as their only active ingredient; 30 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
ENTACAPONE
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
14
Strengths listed
200 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 60307

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020796ORION PHARMA1999-10-193
ANDA 203437AUROBINDO PHARMA LTD2015-06-194
ANDA 207210MACLEODS PHARMS2017-06-052
ANDA 205792AJANTA PHARMA LTD2017-08-311
ANDA 206669SUNSHINE2018-10-032
ANDA 212601ALEMBIC2022-01-042

Official labeling on DailyMed

Showing the 12 most recent of 14 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.