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Active ingredient

Acetylcysteine

34 finished FDA listings contain Acetylcysteine as their only active ingredient; 2 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
ACETYLCYSTEINE
Dosage forms
Inhalant, Injection, Injection, Solution, Solution
Routes
Intravenous, Oral, Respiratory (Inhalation)
Manufacturers / labelers
15
Strengths listed
100 mg/ml · 200 mg/ml · 6 g/30ml
Brand names in FDA listings
Acetadote

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 197

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 073664HOSPIRA1994-08-301
ANDA 074037HOSPIRA1994-08-301
ANDA 072489AM REGENT1995-07-283
ANDA 072547AM REGENT1995-07-283
NDA 021539APOTEX2004-01-232
ANDA 203853ALVOGEN2012-06-215
ANDA 200644FRESENIUS KABI USA2012-11-072
ANDA 204674ALVOGEN2014-02-113
ANDA 207358EUGIA PHARMA2016-02-291
ANDA 091684SAGENT PHARMS INC2017-10-312
ANDA 213693GLENMARK PHARMS2022-02-031
ANDA 215620REGCON HOLDINGS2022-02-231
ANDA 217182ONESOURCE SPECIALTY2023-04-193
ANDA 218397SOMERSET THERAPS LLC2024-06-071
ANDA 219194SOMERSET THERAPS LLC2025-02-123
ANDA 214177CONBA USA2025-03-142

Official labeling on DailyMed

Showing the 12 most recent of 20 labels.

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