Prescription medicine
Acetylcysteine Brand names: Acetadote; first approved as Mucomyst
Acetylcysteine (Mucomyst) is a prescription medicine with an FDA approval on record since 1963. FDA's NDC Directory lists it from 13 generic labelers, and pharmacies paid $2.25 per mL (Acetylcysteine 20% vial (not for injection)) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the acetylcysteine FDA label on DailyMed (effective May 6, 2026, Glenmark Pharmaceuticals Inc., USA); the NDA 13601 record on Drugs@FDA; every acetylcysteine label on DailyMed.
Highlights of the record
FDA label of May 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAcetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI).
Forms and strengths
- 6 g/30ml
- 100 mg/ml
- 200 mg/ml
Solution; injection (solution); inhalant; injection.
On the market
- Earliest approval on file
- September 14, 1963 Mucomyst, Apothecon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first October 14, 1986; 17 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 13 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 8, 2032 Cetylev tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $2.25 per mL Acetylcysteine 20% vial (not for injection)
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2012 1 Class I among all firms' recalls; latest July 24, 2026; 8 more by firms not listed as its makers
- FAERS reports
- 9,369 through July 30, 2026
What is acetylcysteine used for?
From the label: indications and usageAcetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI). Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with an acute ingestion or from repeated supratherapeutic ingestion (RSI) ( 1 ).
FDA pharmacologic class: Antidote, Antidote for Acetaminophen Overdose and Mucolytic.
Source: FDA drug label (Acetylcysteine), Glenmark Pharmaceuticals Inc., USA, effective May 6, 2026 (SPL set f811ddfc-d7c1-4637-ae81-80c38a77cb80), via openFDA; the full label on DailyMed
Is there a generic for acetylcysteine (Mucomyst)?
The FDA approved the first generic acetylcysteine on October 14, 1986. 27 generic applications are approved; 17 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists acetylcysteine from 13 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Mucomyst oral solution; a patent listed only for Cetylev tablets runs to May 8, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1963 earliest approval on file
- 1986 first generic approved
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acetylcysteine (Mucomyst)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.25 per mL (Acetylcysteine 20% vial (not for injection)), up 70% from $1.32 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Acetylcysteine 20% vial (not for injection) (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Acetylcysteine 10% vial (not for injection) | Generic | $2.55 per mL | n/a | +52% |
| Acetylcysteine 20% vial (not for injection) | Generic | $2.25 per mL | n/a | +70% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has acetylcysteine been recalled?
The FDA's Enforcement Report lists 12 recalls naming acetylcysteine since 2012: 1 Class I (the most serious), 11 Class II, 0 Class III; 2 still ongoing. 8 of them are by firms that FDA's NDC Directory does not list as a maker of acetylcysteine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 24, 2026 | Class II | American Regent, Inc. | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde |
| December 17, 2018 | Class II | Promise Pharmacy, LLC not a listed maker | Lack of sterility assurance. |
| September 10, 2018 | Class II | Pharm D Solutions, LLC | Lack of Assurance of Sterility |
| June 22, 2018 | Class II | Akorn, Inc. | CGMP Deviations |
| June 2, 2015 | Class II | The Compounding Pharmacy of America not a listed maker | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility |
| February 14, 2014 | Class I | Ben Venue Laboratories Inc not a listed maker | Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution |
| October 19, 2013 | Class II | Specialty Medicine Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same … |
| July 26, 2013 | Class II | Beacon Hill Medical Pharmacy, P.C. not a listed maker | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the acetylcysteine label say about other medicines?
The acetylcysteine label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | Serious acute hypersensitivity reactions including fatal or life-threatening anaphylaxis, rash, hypotension, wheezing, and/or shortness of breath, have been observed in patients receiving intravenous acetylcysteine for acetaminophen overdose and occurred soon after initiation of the infusion [ see Adverse Reactions … |
Source: FDA drug label (Acetylcysteine), Glenmark Pharmaceuticals Inc., USA, effective May 6, 2026 (SPL set f811ddfc-d7c1-4637-ae81-80c38a77cb80), via openFDA; the full label on DailyMed
What do FAERS reports show for acetylcysteine?
The FDA Adverse Event Reporting System holds 9,369 reports that list acetylcysteine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,754 are coded as a death and 5,080 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antidotes
- the pharmacologic class, with prices and generics
- Acetylcysteine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other