Overview
Acetylcysteine is an antioxidant and glutathione inducer indicated for mucolytic therapy and the treatment of acetaminophen overdose. Acetylcysteine has also been studied for a wide variety of off-label indications with mixed results. Acetylcysteine was granted FDA approval on 14 September 1963.
Background
Acetylcysteine is an antioxidant and glutathione inducer indicated for mucolytic therapy and the treatment of acetaminophen overdose. Acetylcysteine has also been studied for a wide variety of off-label indications with mixed results. Acetylcysteine was granted FDA approval on 14 September 1963.
Indication
Acetylcysteine is indicated for mucolytic therapy and in the management of acetaminophen overdose.
Associated Conditions
- Acetaminophen Overdose
- Chronic Rhinitis
- Corneal Diseases
- Corneal ulceration
- Crusting Rhinitis
- Keratopathy
- Rhinitis
- Sinusitis
- Vasomotor Rhinitis
- Acute Rhinitis
- Subacute Rhinitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/04 | Phase 3 | Not yet recruiting | University Hospital, Lille | ||
2025/03/24 | Phase 2 | Not yet recruiting | |||
2025/03/12 | Not Applicable | Active, not recruiting | |||
2024/12/10 | Phase 2 | Not yet recruiting | Mark Pimentel, MD | ||
2024/08/09 | Phase 4 | Not yet recruiting | |||
2024/04/22 | Not Applicable | Recruiting | National University of Malaysia | ||
2024/02/15 | Phase 1 | Not yet recruiting | Sanjiv Harpavat | ||
2024/02/01 | Phase 3 | Completed | |||
2023/12/11 | Phase 3 | Recruiting | |||
2023/11/08 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-5670 | ORAL, RESPIRATORY (INHALATION) | 200 mg in 1 mL | 9/24/2012 | |
| Hospira, Inc. | 0409-3307 | ORAL, RESPIRATORY (INHALATION) | 100 mg in 1 mL | 8/31/2020 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-946 | INTRAVENOUS | 200 mg in 1 mL | 3/25/2025 | |
| PureTek Corporation | 59088-795 | ORAL | 200 mg in 1 1 | 9/14/2023 | |
| Cumberland Pharmaceuticals Inc. | 66220-207 | INTRAVENOUS | 200 mg in 1 mL | 10/1/2021 | |
| Fresenius Kabi USA, LLC | 63323-963 | INTRAVENOUS | 200 mg in 1 mL | 7/2/2019 | |
| Cardinal Health 107, LLC | 55154-5731 | RESPIRATORY (INHALATION), ORAL | 200 mg in 1 mL | 6/13/2017 | |
| Akorn | 17478-660 | INTRAVENOUS | 200 mg in 1 mL | 3/27/2015 | |
| Allegis Pharmaceuticals, LLC | 28595-719 | ORAL | 150 mg in 1 1 | 4/16/2025 | |
| Cardinal Health 107, LLC | 55154-5730 | RESPIRATORY (INHALATION), ORAL | 100 mg in 1 mL | 6/13/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NAC MEVON 600 MG EFFERVESCENCE TABLETS | SIN15645P | TABLET, EFFERVESCENT | 600mg | 3/15/2019 | |
| MUCODEX POWDER FOR SOLUTION 600MG/SACHET | SIN16304P | POWDER, FOR SOLUTION | 600mg/sachet | 8/18/2021 | |
| FLUIMUCIL A 600 EFFERVESCENT TABLET 600MG (Revised Formula) | SIN07474P | TABLET | 600 mg | 8/17/1993 | |
| FLUIMUCIL A 600 EFFERVESCENT TABLET 600MG (OTC PACK) | SIN15339P | TABLET | 600mg | 10/13/2017 | |
| FLUIMUCIL GRANULES 200 mg/sachet | SIN03415P | GRANULE | 200 mg/sachet | 6/17/1989 | |
| FLUIMUCIL GRANULES 100 MG/SACHET (OTC PACK) | SIN15340P | GRANULE | 100mg | 10/13/2017 | |
| FLUIMUCIL GRANULES 100 mg/sachet | SIN03414P | GRANULE | 100 mg/sachet | 6/17/1989 | |
| HIDONAC SOLUTION FOR INFUSION 5 g/25 ml | SIN12132P | INJECTION | 5 g/25 ml | 11/30/2002 | |
| TREBON-N GRANULES FOR ORAL SUSPENSION 100MG/SACHET | SIN14392P | GRANULE, FOR SUSPENSION | 100mg/sachet | 8/6/2013 | |
| MENTOPIN ACETYLCYSTEINE EFFERVESCENT TABLET 600mg | SIN14971P | TABLET, EFFERVESCENT | 600.00mg | 3/23/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Acetylcysteine Capsules | 国药准字H20000519 | 化学药品 | 胶囊剂 | 12/3/2019 | |
| Acetylcysteine Eye Drops | 国药准字H32025716 | 化学药品 | 眼用制剂 | 7/9/2020 | |
| Acetylcysteine Injection | 国药准字H20183359 | 化学药品 | 注射剂 | 7/26/2023 | |
| Acetylcysteine Injection | 国药准字H20183104 | 化学药品 | 注射剂 | 3/5/2023 | |
| Acetylcysteine Injection | 国药准字H20051788 | 化学药品 | 注射剂 | 4/26/2020 | |
| Acetylcysteine Injection | 国药准字H20249093 | 化学药品 | 注射剂 | 10/16/2024 | |
| Acetylcysteine Injection | 国药准字HJ20250055 | 化学药品 | 注射剂 | 5/13/2025 | |
| Acetylcysteine Granules | 国药准字H20243084 | 化学药品 | 颗粒剂 | 1/23/2024 | |
| Acetylcysteine Granules | 国药准字H20243785 | 化学药品 | 颗粒剂 | 5/21/2024 | |
| Acetylcysteine Granules | 国药准字H20234324 | 化学药品 | 颗粒剂 | 10/18/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| FUMUCIL INJ 100MG/ML | N/A | N/A | N/A | 11/12/1982 | |
| NAC EFFERVESCENT TAB 600MG | N/A | N/A | N/A | 10/20/2010 | |
| ADVANCE MUCOLYTIC POWDER 200MG/SACHET | N/A | N/A | N/A | 9/11/2014 | |
| MADAME PEARL'S MUCOLYTIC 600 (BLACKCURRANT) SACHET 600MG | N/A | karen laboratories o/b karen pharmaceutical co ltd | N/A | N/A | 6/28/2010 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ACETYLCYSTEINE-LINK INJECTION acetylcysteine 2g/10mL concentrated injection ampoule | 170803 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 1/31/2012 |
| DBL ACETYLCYSTEINE injection concentrate acetylcysteine 2 g/ 10 mL injection ampoule | 121503 | Medicine | A | 7/17/2006 | |
| OMEGAPHARM ACETYLCYSTEINE 2000 mg/ 10 mL acetylcysteine solution for inhalation vial | 180343 | Medicine | A | 2/28/2011 | |
| Resverac | 278282 | Medicine | A | 7/26/2016 | |
| MYOSITA PLUS | 437351 | Medicine | A | 1/24/2024 | |
| ACETADOTE acetylcysteine 6g in 30mL concentrated injection vial | 183299 | Medicine | A | 9/23/2011 | |
| OMEGAPHARM ACETYLCYSTEINE 800 mg/4 mL acetylcysteine solution for inhalation vial | 172101 | Medicine | A | 2/28/2011 |