Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Prescription medicine · generic available

Acetylcysteine

Brand names: Acetadote

Drug class: Antidote, Antidote for Acetaminophen Overdose, Mucolytic

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
2Recalls (FDA reports)
15Companies
1994First FDA approval on file

Quick answers

What is Acetylcysteine used for?
The FDA-approved label (Acetadote, Cumberland Pharmaceuticals Inc., April 30, 2025) says: “ACETADOTE 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). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Acetylcysteine have a boxed warning?
No. None of the 20 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Acetylcysteine?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Acetylcysteine been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started July 24, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Acetylcysteine?
15 companies list prescription products of Acetylcysteine in the FDA NDC Directory, including Fresenius Kabi USA, LLC, American Regent, Inc. and Somerset Therapeutics, LLC.

What Acetylcysteine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

ACETADOTE 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). …

— FDA label: Acetadote, Cumberland Pharmaceuticals Inc., effective April 30, 2025. Read the full label on DailyMed →

The FDA has 20 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 20 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsSolution · Injection, solution · Inhalant · Injection
RouteRespiratory (inhalation) · Intravenous · Oral
Prescription products30 in the FDA NDC Directory
Brand namesAcetadote

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Acetylcysteine, by strength and form
Strength and formGeneric or brandPharmacies pay
acetylcysteine 100 mg/mL
inhalant		 Generic $2.57 per mL
acetylcysteine 100 mg/mL
solution		 Generic $0.6331–$2.57 per mL
6 packages, lowest to highest
acetylcysteine 200 mg/mL
inhalant		 Generic $2.34 per mL
acetylcysteine 200 mg/mL
solution		 Generic $0.7432–$2.34 per mL
8 packages, lowest to highest

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA021539
ACETADOTE		 ApotexJanuary 23, 2004 13, latest July 23, 2025
2025: Labeling · 2024: Efficacy · 2021: Labeling

Generic approvals (15)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. July 24, 2026 · Class II · Ongoing · D-0797-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. — American Regent, Inc.

  2. July 24, 2026 · Class II · Ongoing · D-0796-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. — American Regent, Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)307718, 307719, 465377, 582119
SPL set ID of the quoted label472f158a-5ab9-4308-8e49-1116e6ea3d39
FDA labels (SPL)20
FDA applicationsNDA021539, 15 ANDA
Active ingredients (FDA)ACETYLCYSTEINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Acetadote, Cumberland Pharmaceuticals Inc., effective April 30, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers