Data / Drug companies / Acetylcysteine
Acetylcysteine: 15 companies and 34 products in the FDA NDC directory
Acetylcysteine is listed in the FDA National Drug Code Directory by 15 companies, with 34 products in commercial distribution. 32 of the products (94.1%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are solution; injection, solution; inhalant, and the newest product started marketing on March 31, 2026.
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- Companies listing it
- 15
- Products
- 34
- Generic (ANDA) products
- 32 (94.1%)
- Application numbers
- 16
- Routes
- Respiratory (inhalation), Intravenous, Oral
- Brand names
- Acetadote
- openFDA record search
- api.fda.gov
Companies that list acetylcysteine
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 10 | solution; injection, solution | Generic drugs (ANDA) | March 31, 2014 |
| American Regent, Inc. | 4 | inhalant | Generic drugs (ANDA) | October 1, 1995 |
| Somerset Therapeutics, LLC | 4 | solution; injection, solution | Generic drugs (ANDA) | March 4, 2025 |
| Cameron Pharmaceuticals | 2 | solution | Generic drugs (ANDA) | August 21, 2025 |
| Cardinal Health 107, LLC | 2 | inhalant | Generic drugs (ANDA) | May 6, 2011 |
| Hospira, Inc. | 2 | solution | Generic drugs (ANDA) | June 1, 2005 |
| Sagent Pharmaceuticals | 2 | injection, solution | Generic drugs (ANDA) | February 15, 2022 |
| Cumberland Pharmaceuticals Inc. | 1 | injection, solution | New drug applications (NDA) | January 23, 2004 |
| Eugia US LLC | 1 | injection, solution | Generic drugs (ANDA) | February 29, 2016 |
| Glenmark Pharmaceuticals Inc., USA | 1 | injection, solution | Generic drugs (ANDA) | September 25, 2024 |
| Hikma Pharmaceuticals USA Inc. | 1 | injection, solution | Generic drugs (ANDA) | March 31, 2026 |
| Indoco Remedies Limited | 1 | injection | Generic drugs (ANDA) | March 1, 2022 |
| Onesource Specialty Pharma Limited | 1 | injection, solution | Generic drugs (ANDA) | April 26, 2023 |
| Padagis US LLC | 1 | injection | Authorized generics (NDA) | December 20, 2012 |
| Xellia Pharmaceuticals USA LLC | 1 | injection, solution | Generic drugs (ANDA) | June 10, 2023 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Solution | 15 | 44.1% |
| Injection, solution | 11 | 32.4% |
| Inhalant | 6 | 17.6% |
| Injection | 2 | 5.9% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 32 | 94.1% |
| New drug applications (NDA) | 1 | 2.9% |
| Authorized generics (NDA) | 1 | 2.9% |
Pharmacologic classes
| Class | Products |
|---|---|
| Antidote | 34 |
| Antidote for Acetaminophen Overdose | 34 |
| Mucolytic | 34 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.