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Active ingredient

Etodolac

103 finished FDA listings contain Etodolac as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ETODOLAC
Dosage forms
Capsule, Tablet, Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
30
Strengths listed
200 mg/1 · 300 mg/1 · 400 mg/1 · 500 mg/1 · 600 mg/1
Brand names in FDA listings
Etodolac Er

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 24605

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
ANDA 075074TARO PHARM INDS1998-03-1113
ANDA 075078TARO1998-04-305
ANDA 075126ANI PHARMS1999-09-169
ANDA 075419APOTEX2000-07-283
ANDA 075665TEVA2000-07-314
ANDA 076004APOTEX2002-12-0319
ANDA 076174TARO2003-03-1311
ANDA 091134ZYDUS PHARMS2014-01-2311
ANDA 208834AMNEAL PHARMS CO2018-06-0713
ANDA 209888ADAPTIS2018-11-304
ANDA 210704PHARMACO2020-12-164
ANDA 204729IPCA LABS LTD2024-05-012
ANDA 205448IPCA LABS LTD2024-08-013
ANDA 214872AUROBINDO PHARMA LTD2026-07-152

Official labeling on DailyMed

Showing the 12 most recent of 73 labels.

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