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Active ingredient

Acamprosate

11 finished FDA listings contain Acamprosate as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ACAMPROSATE, ACAMPROSATE CALCIUM
Dosage forms
Tablet, Delayed Release
Routes
Oral
Manufacturers / labelers
10
Strengths listed
333 mg/1
Brand names in FDA listings
Acamprosate Calcium

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 82819

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 202229GLENMARK PHARMS LTD2013-07-163
ANDA 200142MYLAN2014-03-112
ANDA 205995ZYDUS PHARMS2017-05-263
ANDA 219904BIONPHARMA2025-09-182
ANDA 218984SOMERSET THERAPS LLC2026-03-161

Official labeling on DailyMed

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