Active substance
Acetylcysteine
- SFDA 6
- US FDA 33
- Health Canada 3
- US price lines 5
- NHS prices 5
- WHO EML 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ACC 200MG POWDER FOR ORAL SOLUTION | 200 mg | Powder for oral solution · Oral use | 20 Sachet | SAR 11.40 | Generic · OTC | HEXAL | Valid |
| ACC LONG 600MG EFFERVESCENT TABLETS | 600 mg | Effervescent tablet · Oral use | 10 Blister | SAR 16.55 | Generic · OTC | HEXAL | Valid |
| ACETYLCYSTEINE 200mg/ml Injection | 200 mg/ml | Injection · Intravenous use | 10 Ampoule | SAR 99.05 | NCE · Prescription | AURUM PHARMACEUTICALS LTD | Valid |
| FLUIMUCIL 200MG/1GM GRANULES FOR ORAL SOLUTION | 0.2 mg | Effervescent granules · Oral use | 30 Sachet | SAR 17.10 | Generic · Prescription | ZAMBON SWITZERLAND LTD | Valid |
| ACETYLCISTEINE EFFE INSTANT 200MG SACHET | 200 mg | Effervescent powder · Oral use | 10 Sachet | SAR 5.20 | Generic · OTC | SEDICO | Withdrawn by regulatory authority · Not Marketed |
| FLUIMUCIL 100MG/1GM GRANULES FOR ORAL SOLUTION | 0.1 mg | Effervescent granules · Oral use | 30 Sachet | SAR 4.65 | Generic · Prescription | ZAMBON SWITZERLAND LTD | Invalid · Not Marketed |
Indications — CHI Daman Drug Formulary
ACUTE BIPOLAR I DEPRESSION; ACUTE LIVER FAILURE; ANXIETY DISORDERS; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ACETYLCYSTEINE | 10% | solution · inhalation, oral | HOSPIRA | Prescription | 30 Aug 1994 |
| ACETYLCYSTEINE | 20% | solution · inhalation, oral | HOSPIRA | Prescription | 30 Aug 1994 |
| ACETYLCYSTEINE | 10% | solution · inhalation, oral | AM REGENT | Prescription | 28 Jul 1995 |
| ACETYLCYSTEINE | 20% | solution · inhalation, oral | AM REGENT | Prescription | 28 Jul 1995 |
| ACETADOTE | 6GM/30ML (200MG/ML) | injectable · intravenous | APOTEX | Prescription | 23 Jan 2004 |
| ACETYLCYSTEINE | 20% | solution · inhalation, oral | ALVOGEN | Prescription | 21 Jun 2012 |
| ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | injectable · intravenous | FRESENIUS KABI USA | Prescription | 7 Nov 2012 |
| ACETYLCYSTEINE | 10% | solution · inhalation, oral | ALVOGEN | Prescription | 11 Feb 2014 |
| ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | injectable · intravenous | RISING | Prescription | 24 Mar 2015 |
| ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | injectable · intravenous | EUGIA PHARMA | Prescription | 29 Feb 2016 |
| ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | injectable · intravenous | SAGENT PHARMS INC | Prescription | 31 Oct 2017 |
| ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | injectable · intravenous | ZYDUS PHARMS | Prescription | 20 Jul 2018 |
| ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | injectable · intravenous | GLENMARK PHARMS | Prescription | 3 Feb 2022 |
| ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | injectable · intravenous | REGCON HOLDINGS | Prescription | 23 Feb 2022 |
| ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | injectable · intravenous | ONESOURCE SPECIALTY | Prescription | 19 Apr 2023 |
| ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | injectable · intravenous | SOMERSET THERAPS LLC | Prescription | 7 Jun 2024 |
| ACETYLCYSTEINE | 10%; 20% | solution · inhalation, oral | SOMERSET THERAPS LLC | Prescription | 12 Feb 2025 |
| ACETYLCYSTEINE | 10%; 20% | solution · inhalation, oral | CONBA USA | Prescription | 14 Mar 2025 |
| MUCOMYST | 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · inhalation, oral | APOTHECON | Discontinued | 14 Sep 1963 |
| MUCOSIL-10 | 10% | solution · inhalation, oral | DEY | Discontinued | 14 Oct 1986 |
| MUCOSIL-20 | 20% | solution · inhalation, oral | DEY | Discontinued | 14 Oct 1986 |
| ACETYLCYSTEINE | 10% | solution · inhalation, oral | ROXANE | Discontinued | 30 Apr 1992 |
| ACETYLCYSTEINE | 20% | solution · inhalation, oral | ROXANE | Discontinued | 30 Apr 1992 |
| ACETYLCYSTEINE | 10% | solution · inhalation, oral | ROXANE | Discontinued | 30 Sep 1992 |
| ACETYLCYSTEINE | 20% | solution · inhalation, oral | ROXANE | Discontinued | 30 Sep 1992 |
8 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ACETYLCYSTEINE SOLUTION | 02243098 | 200 MG / ML | SOLUTION · ORAL; INHALATION; INTRAVENOUS | SANDOZ CANADA INCORPORATED |
| ACETYLCYSTEINE SOLUTION USP | 02459906 | 200 MG / ML | SOLUTION · ORAL; INTRAVENOUS; INHALATION | HIKMA CANADA LIMITED |
| ACETYLCYSTEINE SOLUTION USP | 02538431 | 200 MG / ML | SOLUTION · INTRAVENOUS; ORAL; INHALATION | STERIMAX INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION) | $0.63561 | per ML | 23 Sep 2026 |
| US NADAC | ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION) | $0.9656 | per ML | 18 Mar 2026 |
| US NADAC | ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION) | $2.55393 | per ML | 23 Sep 2026 |
| US NADAC | ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION) | $0.73709 | per ML | 23 Sep 2026 |
| US NADAC | ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION) | $2.24549 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Acetylcysteine 200mg oral powder sachets sugar free | £112.50 | 30 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Acetylcysteine 2g/10ml solution for infusion ampoules | £21.26 | 10 ampoule | 1 Oct 2026 |
| NHS Drug Tariff | Acetylcysteine 5% eye drops | £80.95 | 10 ml | 1 Oct 2026 |
| NHS Drug Tariff | Acetylcysteine 600mg capsules | £85.00 | 30 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Acetylcysteine 600mg effervescent tablets sugar free | £5.50 | 30 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 4.2. Antidotes and other substances used in poisonings > Specific · core
Exposure to or harmful effects of undetermined intent of analgesics, antipyretics or nonsteroidal anti-inflammatory drugs
Parenteral > General injections > IV: 200 mg per mL in 10 mL ampoule
Safety signals and safety-related labeling changes
- US FDA 26 Nov 2024 ACETADOTE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.