Drug
Who makes acetylcysteine?
15 companies list acetylcysteine as a human prescription drug, including under the names ACETADOTE. Forms: inhalant; injection; injection, solution; solution. Routes: intravenous, oral, respiratory (inhalation).
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing acetylcysteine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Fresenius Kabi USA, LLCUnited States | injection, solution; solution | ANDAANDA200644, ANDA203853, ANDA204674 | 7 | 6 |
| American Regent, Inc.United States | inhalant | ANDAANDA072489, ANDA072547 | 4 | 5 |
| Somerset Therapeutics Private LimitedIndia | injection, solution; solution | ANDAANDA218397, ANDA219194 | 4 | 1 |
| Cardinal Health 418, Inc.United States | inhalant | ANDAANDA072489, ANDA072547 | 2 | 34 |
| Hospira, Inc.United States | solution | ANDAANDA073664, ANDA074037 | 2 | 7 |
| Cameron Pharmaceuticals | solution | ANDAANDA214177 | 2 | 0 |
| Glenmark Pharmaceuticals Inc., USAIndia | injection, solution | ANDAANDA213693 | 1 | 9 |
| Indoco Remedies LimitedIndia | injection | ANDAANDA215620 | 1 | 7 |
| Hikma Pharmaceuticals USA Inc.United States | injection, solution | ANDAANDA217182 | 1 | 4 |
| ONESOURCE SPECIALTY PHARMA LIMITEDIndia | injection, solution | ANDAANDA217182 | 1 | 3 |
| Xellia Pharmaceuticals ApSDenmark | injection, solution | ANDAANDA217182 | 1 | 3 |
| Padagis Israel Pharmaceuticals LtdUnited States | injection | NDA AUTHORIZED GENERICNDA021539 | 1 | 2 |
| Cumberland Pharmaceuticals Inc. | injection, solution | NDANDA021539 | 1 | 0 |
| Eugia US LLC | injection, solution | ANDAANDA207358 | 1 | 0 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA091684 | 1 | 0 |
Bulk ingredient listings
- Pharmazell (India) Private LimitedIndia · 7 NDC
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 1 NDC
- Fujian South Pharmaceutical Co. Ltd.China · 1 NDC
- MAEDA INCUnited States · 1 NDC
- Moehs Catalana SLSpain · 1 NDC
- NIPPON RIKA CO., LTD.Japan · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Willow Birch Pharma, LLCUnited States · 1 NDC
Orange Book patents
5 unexpired patents list acetylcysteine as the active ingredient, expiring between Jul 2031 and May 2032. Application holders: APOTEX INC, ARBOR PHARMACEUTICALS LLC.
Enquiry
Common questions
- Who makes acetylcysteine?
- 15 companies list acetylcysteine as a human prescription drug in the openFDA NDC Directory, led by Fresenius Kabi USA, LLC, American Regent, Inc., Somerset Therapeutics Private Limited, Cardinal Health 418, Inc., Hospira, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic ACETADOTE?
- 13 companies list acetylcysteine under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies acetylcysteine active ingredient?
- 9 companies list acetylcysteine as a bulk ingredient, including Pharmazell (India) Private Limited, FIS FABBRICA ITALIANA SINTETICI SPA, Fujian South Pharmaceutical Co. Ltd., MAEDA INC.