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Acetylcysteine

Acetylcysteine is a medicine used in two main ways: as an antidote to prevent or lessen liver injury after an acetaminophen overdose, and as an add-on treatment to thin thick, sticky mucus in lung and airway conditions.

Brand name Acetadote
Drug classes Antidote For Acetaminophen Overdose
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 7 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 4, 2026 🚨Recall on record
Other forms & routes:
Oral inhalation
Acetylcysteine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Acetylcysteine is the standard antidote for acetaminophen (Tylenol) overdose, shielding the liver by restoring glutathione, its natural protector, and possibly neutralizing the toxic by-product directly. Inhaled, it is an older add-on that thins thick mucus, and it has been around since about 1982 and is available generically. Most people handle it fairly well, with nausea, vomiting, flushing or an itchy rash the usual complaints. The injection can trigger a serious allergic reaction, usually soon after it starts, so staff give and watch it closely, especially in people with asthma. It is time-sensitive, working best within 8 to 10 hours of the overdose, so seek help even before symptoms.

Clinical pearls

  • Doctors decide whether to treat using an acetaminophen blood level drawn at least 4 hours after the overdose.
  • Inhaled, it loosens mucus so the volume can rise, and coughing it up or suction keeps the airway clear.
  • If you have asthma, say so before either form, because airway tightening can worsen and treatment may need to stop.
  • After the injection, pumping and discarding breast milk for 30 hours may be considered, since no human milk data exist.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection, Inhalation solution (nebulizer), Inhaler
Earliest FDA record1963
Companies listing it with the FDA32
FDA label last updatedAug 15, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide — a plain-language walkthrough of Acetylcysteine, written from its FDA label.

What Acetylcysteine is used for

▾

Acetylcysteine is used for different purposes depending on the product.

  • Acetadote and Acetylcysteine Injection (intravenous): antidote to prevent or lessen liver injury after acetaminophen overdose, from a single large ingestion or repeated higher-than-safe doses. Acetadote is labeled for adults and children weighing 5 kg or more.
  • Acetylcysteine solution (oral and inhalation): antidote for acetaminophen overdose when given by mouth.
  • Acetylcysteine solution and inhalant: add-on therapy for thick, sticky or dried mucus.
  • Lung conditions listed: chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung.
  • Acute lung conditions listed: pneumonia, bronchitis and tracheobronchitis.
  • Other uses: cystic fibrosis lung complications, tracheostomy care, complications after surgery, use during anesthesia, post-traumatic chest conditions and atelectasis (collapsed lung areas) from mucus blockage.
  • Diagnostic bronchial studies: bronchograms, bronchospirometry and bronchial wedge catheterization.

How Acetylcysteine works

▾

Too much acetaminophen overwhelms the liver's usual safe disposal routes. More of the drug is turned into a harmful by-product, which uses up the liver's glutathione and then damages liver cells.

Acetylcysteine likely protects the liver by maintaining or restoring glutathione, or by helping detoxify the harmful by-product. It works best when started early, mainly within 8 to 10 hours.

Acetylcysteine dosage

▾

The way acetylcysteine is given depends on the product.

  • Injection (Acetadote, Acetylcysteine Injection): given into a vein by healthcare staff, starting with a loading dose. Treatment may continue for about 20 to 21 hours in some situations.
  • Inhalation solution: nebulized through a face mask, mouthpiece or tracheostomy, usually 3 to 4 times a day for most patients. A tent or croupette is sometimes used, with the method tailored to the patient.
  • The 20% solution may be diluted. The 10% solution can be used undiluted.
  • Opened vials have no preservative. Refrigerate the remainder and use it for inhalation within 96 hours.

Follow your prescriber and the product label.

Dosing details from the FDA-approved label

From the Acetylcysteine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Acute acetaminophen ingestion (Acetadote) - total dosage
    • 300 mg/kg given intravenously as either 3 separate doses infused over a total of 21 hours OR 2 separate doses infused over a total of 20 hours
    • Patients 40 kg or less should receive the three-bag regimen; for patients weighing 41 kg or greater, the three-bag regimen may be preferred for those with early signs of severe liver injury or a large acetaminophen ingestion
  • Acute acetaminophen ingestion - time of ingestion unknown
    • Administer a loading dose of ACETADOTE immediately
    • Obtain an acetaminophen concentration to determine need for continued treatment
  • Acute acetaminophen ingestion - acetaminophen concentration cannot be obtained (or is unavailable or uninterpretable) within the 8-hour interval after ingestion, or clinical evidence of acetaminophen toxicity
    • Administer a loading dose of ACETADOTE immediately and continue treatment for a total of two doses over 20 hours or three doses over 21 hours
  • Acute acetaminophen ingestion - patient presents more than 8 hours after ingestion and time of ingestion is known
    • Administer a loading dose of ACETADOTE immediately
    • Obtain acetaminophen concentration to determine need for continued treatment
  • Acute acetaminophen ingestion - patient presents less than 8 hours after ingestion, time of ingestion known and acetaminophen concentration known
    • Use the revised Rumack-Matthew nomogram (Figure 1) to determine whether or not to initiate treatment with ACETADOTE
  • Acute acetaminophen ingestion (acetylcysteine injection, generic label) - total dosage
    • 300 mg/kg given intravenously as 3 separate doses
    • Total recommended infusion time for 3 doses is 21 hours
    • Adult and pediatric dosage; weight-based dosage and dilution in Full Prescribing Information
  • Repeated supratherapeutic acetaminophen ingestion
    • Obtain acetaminophen concentration and other laboratory tests to guide treatment
    • Rumack-Matthew nomogram does not apply
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION General Acetylcysteine solution is available in rubber stoppered glass vials containing 4 or 30 mL. The 20% solution may be diluted to a lesser concentration with either sodium chloride for injection, sodium chloride for inhalation, sterile water for injection, or sterile water for inhalation. The 10% solution may be used undiluted. Acetylcysteine solution does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution. If only a portion of the solution in a vial is used, store the remainder in a refrigerator and use for inhalation only within 96 hours. NEBULIZATION—FACE MASK, MOUTH PIECE, TRACHEOSTOMY When nebulized into a face mask, mouth piece, or tracheostomy, 1 to 10 mL of the 20% solution or 2 to 20 mL of the 10% solution may be given every 2 to 6 hours; the recommended dose for most patients is 3 to 5 mL of the 20% solution or 6 to 10 mL of the 10% solution 3 to 4 times a day. NEBULIZATION TENT, CROUPETTE In special circumstances it may be necessary to nebulize into a tent or croupette, and this method of use must be individualized to take into account the available equipment and the patient's particular needs. This form of administration requires very large volumes of the solution, occasionally as much as 300 mL during a single treatment period. If a tent or croupette must be used, the recommended dose is the volume of acetylcysteine solution (using 10% or 20%) that will maintain a very heavy mist in the tent or croupette for the desired period. Administration for intermittent or continuous prolonged periods, including overnight, may be desirable. DIRECT INSTILLATION When used by direct instillation, 1 to 2 mL of a 10% to 20% solution may be given as often as every hour. When used for the routine nursing care of patients with tracheostomy, 1 to 2 mL of a 10% to 20% solution may be given every 1 to 4 hours by instillation into the tracheostomy. Acetylcysteine solution may be introduced directly into a particular segment of the bronchopulmonary tree by inserting (under local anesthesia and direct vision) a small plastic catheter into the trachea. Two to 5 mL of the 20% solution may then be instilled by means of a syringe connected to the catheter. Acetylcysteine solution may also be given through a percutaneous intratracheal catheter.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Acetylcysteine side effects

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Common side effects

  • Rash
  • Hives (urticaria) or facial flushing
  • Itching (pruritus)
  • Nausea
  • Vomiting
  • Fast heartbeat (tachycardia)

When to get medical help

  • Get emergency help for trouble breathing, wheezing, throat tightness, low blood pressure or swelling. These can be signs of a serious allergic reaction.
  • Tell your care team right away if you have a rash, hives or itching that goes beyond mild flushing.
  • If you have asthma and develop worsening wheezing or bronchospasm (airway tightening), tell your care team immediately.
  • With the injection, too much fluid can cause low sodium, seizures and death. Staff adjust the volume for people under 40 kg or on fluid limits.
  • With oral use for overdose, tell your care team about widespread hives or other allergic symptoms.
  • If liver failure causes confusion (encephalopathy), tell your care team, since treatment may need to stop.

Most side effects are allergy-type skin reactions, especially with the injection.

  • Rash
  • Hives or facial flushing
  • Itching
  • Nausea and vomiting
  • Fast heartbeat

Seek help right away for wheezing, shortness of breath, low blood pressure, swelling or throat tightness. These can signal a serious allergic reaction.

Acetylcysteine warnings and precautions

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  • Serious allergic reactions can happen with the injection, usually soon after the infusion starts. Fatal anaphylaxis has been reported after approval.
  • People with asthma or a history of bronchospasm need close monitoring.
  • The injection can cause fluid overload, leading to low sodium, seizures and death. The volume is reduced for people under 40 kg or on fluid restriction.
  • Inhaled use can increase the volume of loosened secretions, so keep the airway clear.
  • Oral use for overdose has rarely caused widespread hives.
  • If encephalopathy from liver failure appears, treatment should be stopped.

Acetylcysteine interactions

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No drug interaction studies have been conducted with acetylcysteine, so specific interactions are not described.

Interactions listed in the FDA-approved label

From the Acetylcysteine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Drug-drug interactions (any): No drug-drug interaction studies have been conducted.
Read the label’s full interactions text

Drug Interactions Drug stability and safety of acetylcysteine when mixed with other drugs in a nebulizer have not been established.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Acetylcysteine against a supplement or herb →

Before taking Acetylcysteine

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  • Do not use the injection if you have had an allergic reaction to acetylcysteine.
  • Tell your care team if you have asthma or have had bronchospasm.
  • Tell your care team if you are on fluid restriction or weigh less than 40 kg.
  • Pregnancy: acetylcysteine crosses the placenta. Delaying overdose treatment may raise the risk to mother and baby.
  • Breastfeeding: there are no milk data. Pumping and discarding milk for 30 hours after the injection may be considered.
  • Children: injection use in children 5 kg and over is based on clinical practice.
  • Severe liver damage (cirrhosis) slows how fast the body clears acetylcysteine.

Acetylcysteine overdose

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Too much acetylcysteine can cause fatal or life-threatening problems, including anaphylaxis, brain swelling (cerebral edema) and hemolytic-uremic syndrome (HUS), which involves red blood cell breakdown and kidney injury. Stop acetylcysteine if overdose is suspected. Call Poison Control at 1-800-222-1222 for guidance, including whether hemodialysis is appropriate.

What Acetylcysteine does in the body

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Acetylcysteine has been shown to reduce the extent of liver injury after acetaminophen overdose. Benefit is seen mainly when treatment starts within 8 to 10 hours. Efficacy drops steadily after 8 hours. Treatment started 15 to 24 hours after ingestion has limited benefit, but it should not be withheld because the reported time of ingestion may be wrong.

How your body processes Acetylcysteine

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After an intravenous dose, acetylcysteine levels fall with a mean half-life of about 5.6 hours in adults. In newborns it is longer, about 11 hours. About 83% is bound to proteins in the blood. Kidney clearance accounts for about 30% of total clearance. In people with severe liver cirrhosis, the half-life rises by about 80%.

How to store Acetylcysteine

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Store unopened vials at 20 ° - 25 °C (68 ° - 77 °F); excursions permitted to 15 °- 30 °C (59 ° – 86 °F) (see USP Controlled Room Temperature). store the remaining undiluted portion in a refrigerator and use within 96 hours.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Acetylcysteine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Acetylcysteine — the kind of thing our pharmacy team would talk through with you at the counter.

What is acetylcysteine used for?

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It has two main uses. It is an antidote that helps protect the liver after an acetaminophen overdose. In inhaled form, it also helps loosen thick, sticky mucus in many lung conditions.

How is it given?

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The injection is given into a vein by healthcare staff, usually starting with a loading dose. The inhaled solution is breathed in as a mist, often a few times a day. Your prescriber will set the schedule, so follow their directions.

What side effects should I expect?

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The most common ones are rash, hives, facial flushing and itching. Some people have nausea, vomiting or a fast heartbeat. Mild flushing often fades even while the infusion continues.

When should I get help right away?

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Get help for wheezing, shortness of breath, throat tightness, swelling or feeling faint. These can be signs of a serious allergic reaction. If you have asthma, tell your care team before starting.

Is it safe in pregnancy or while breastfeeding?

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Acetylcysteine crosses the placenta. The label says delaying treatment of an acetaminophen overdose may raise risks for both mother and baby. For breastfeeding after the injection, you may consider pumping and discarding milk for 30 hours.

Does it interact with other medicines?

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No drug interaction studies have been done. Still, tell your pharmacist and care team about everything you take.

Is Acetylcysteine available over the counter?

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No. Acetylcysteine is a prescription medicine: every Acetylcysteine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Acetylcysteine first available?

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The earliest FDA record we hold for Acetylcysteine is from 1963: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Acetylcysteine was first used.

Who makes Acetylcysteine?

▾
32 companies list Acetylcysteine products in the FDA's NDC Directory, including Fresenius Kabi USA, LLC, PharmaZell GmbH, American Regent, Inc.. That count includes repackagers and distributors as well as manufacturers, so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Acetylcysteine on HelloPharmacist

🌿Drug & Supplement CheckerAcetylcysteine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Acetylcysteine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Acetylcysteine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Acetylcysteine forms and strengths (how it comes)

Acetylcysteine is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a vein
Brands Acetadote
How this form is used
What it may be used for
  • Acetadote is an antidote to prevent or lessen liver injury after acetaminophen overdose in adults and children 5 kg or more.
  • Acetylcysteine Injection is used to prevent or lessen liver injury after a potentially toxic acetaminophen ingestion.
Important instructions
  • Acetadote is given into a vein, starting with a loading dose.
  • Acetylcysteine Injection is given into a vein, often after an acetaminophen blood level is checked at least 4 hours after ingestion.
  • Acetylcysteine Injection volume is reduced for patients under 40 kg or on fluid restriction.
Available strengths 2 strengths
200 mg/mL 6 g/30 mL
29 FDA-listed product records ⓘ

Inhalation solution (nebulizer)

By mouth · Inhaled
How this form is used
What it may be used for
  • Acetylcysteine solution is add-on therapy for thick, abnormal mucus in chronic and acute lung disease, cystic fibrosis complications, tracheostomy care and atelectasis.
  • Acetylcysteine solution is also used before certain diagnostic bronchial studies.
  • Acetylcysteine given by mouth is an antidote for acetaminophen overdose.
Important instructions
  • Acetylcysteine 20% solution may be diluted, and the 10% solution may be used undiluted.
  • Acetylcysteine is nebulized through a face mask, mouthpiece or tracheostomy, usually 3 to 4 times a day for most patients.
  • Acetylcysteine has no preservative, so an opened vial's remainder should be refrigerated and used for inhalation within 96 hours.
Available strengths 2 strengths
100 mg/mL 200 mg/mL
24 FDA-listed product records ⓘ

Inhaler

By mouth · Inhaled
How this form is used
What it may be used for
  • Acetylcysteine inhalant is add-on therapy for thick, abnormal mucus in lung conditions.
  • Acetylcysteine given by mouth is an antidote for acetaminophen overdose.
Important instructions
  • Acetylcysteine inhalant is supplied in vials, and the 20% strength may be diluted.
  • Acetylcysteine inhalant is nebulized through a face mask, mouthpiece or tracheostomy.
  • Acetylcysteine inhalant leftovers should be refrigerated and used within 96 hours.
Available strengths 2 strengths
100 mg/mL 200 mg/mL
13 FDA-listed product records ⓘ

Acetylcysteine on the U.S. market: products, makers and brands

How Acetylcysteine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

32 companies list 85 Acetylcysteine product records with the FDA, mostly as injection, inhalation solution (nebulizer), inhaler; the earliest marketing or approval year on record is 1963. Brand names on the directory include Acetadote; the rest are generics.

3
Dose forms ⓘ
32
Labelers (makers, repackagers, distributors)
2
Brand names
85
FDA-listed product records ⓘ
1963
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (19) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Fresenius Kabi USA, LLC19%
PharmaZell GmbH12%
American Regent, Inc.11%
Sagent Pharmaceuticals6%
Cardinal Health 107, LLC5%
Somerset Therapeutics, LLC5%
Other makers44%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Acetylcysteine is used (Medicaid data)

A general measure of how commonly Acetylcysteine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Acetylcysteine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

15,447
Medicaid prescriptions filled (Q1–Q4 2025)
$2.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Acetylcysteine prescribed? Of the 1,601 medications we measure, Acetylcysteine ranks #850 by Medicaid prescriptions — more than 47% of them.

Where Acetylcysteine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #850 of 1,601
#845 Tinidazole 15,770 Rx #846 Treprostinil 15,732 Rx #847 Cisplatin Injection 15,540 Rx #848 Salmeterol Oral Inhala... 15,481 Rx #849 Oxiconazole 15,480 Rx #850 Acetylcysteine 15,447 Rx #851 Lenalidomide 15,430 Rx #852 Acetylcysteine Oral In... 15,323 Rx #853 Hydrochlorothiazide /... 15,067 Rx #854 Solriamfetol 15,014 Rx #855 Difluprednate Ophthalm... 14,855 Rx

Utilization by Acetylcysteine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 200 mg/mL inhalation solution is the most-dispensed Acetylcysteine product — about 62% of these Medicaid prescriptions.

acetylcysteine 200 MG/ML Inhalation Solution Most dispensed

9,612 Medicaid prescriptions (Q1–Q4 2025) 62% of Acetylcysteine prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $133 per prescription (gross)

Summed across the 9 of 28 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 307719

acetylcysteine 100 MG/ML Inhalation Solution

5,711 Medicaid prescriptions (Q1–Q4 2025) 37% of Acetylcysteine prescriptions shown $918,159 gross reimbursement (before rebates) ≈ $161 per prescription (gross)

Summed across the 6 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 307718

30 ML acetylcysteine 200 MG/ML Injection

124 Medicaid prescriptions (Q1–Q4 2025) <1% of Acetylcysteine prescriptions shown $24,635 gross reimbursement (before rebates) ≈ $199 per prescription (gross)

Summed across the 5 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 465377

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Acetylcysteine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 20 of 71 listed Acetylcysteine NDCs with Medicaid activity.

Compare Acetylcysteine products

A representative set of FDA-listed product records for Acetylcysteine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 85 of 85 products — FDA National Drug Code Directory. See every product, package size and price: browse all 85 Acetylcysteine NDCs →

Acetylcysteine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Acetylcysteine recall since July 2021, covering 2 product listings. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Jul 24, 2026 · American Regent, Inc.
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.… Lots: Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027. FDA record D-0797-2026 →
  • 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.… Lots: Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027 FDA record D-0796-2026 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Acetylcysteine RxCUI 197 5 dose forms · 9 strengths
  1. Dose form (SCDF) Inhalation Solution RxCUI 2108211 In current FDA listings
    Clinical drug / strength (SCD) 100 MG/ML RxCUI 307718 200 MG/ML RxCUI 307719
  3. Dose form (SCDF) Ophthalmic Solution RxCUI 377405 No current FDA listing
    Clinical drug / strength (SCD) 25 MG/ML RxCUI 2693999 50 MG/ML RxCUI 106781 200 MG/ML RxCUI 106783
  4. Dose form (SCDF) Oral Capsule RxCUI 437272 No current FDA listing
    Clinical drug / strength (SCD) 500 MG RxCUI 664732 600 MG RxCUI 606971
  5. Dose form (SCDF) Oral Tablet RxCUI 370532 No current FDA listing
    Clinical drug / strength (SCD) 600 MG RxCUI 429042

Look up RxCUI 197 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Acetylcysteine brand names

Acetylcysteine is sold under one brand name in the FDA directory — Acetadote. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Acetadote

Who makes Acetylcysteine: manufacturers and labelers

32 companies list Acetylcysteine products with the FDA. By number of product records, the largest are Fresenius Kabi USA, LLC, PharmaZell GmbH, American Regent, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Fresenius Kabi USA, LLC 16 PharmaZell GmbH 10 American Regent, Inc. 9 Sagent Pharmaceuticals 5 Cardinal Health 107, LLC 4 Somerset Therapeutics, LLC 4 Hospira, Inc. 4 Padagis US LLC 3 Almaject, Inc. 2 Nippon Rika Co., Ltd. 2 Exela Pharma Sciences, LLC 2 Eugia US LLC 2 Cumberland Pharmaceuticals Inc. 2 Cameron Pharmaceuticals 2 Zydus Pharmaceuticals (USA) Inc. 1 Zydus Lifesciences Limited 1 Xellia Pharmaceuticals USA LLC 1 Willow Birch Pharma, LLC 1 Stelis Biopharma Limited 1 Spectrum Laboratory Products, Inc. 1 Akorn 1 Zydus Pharmaceuticals USA Inc. 1 Professional Compounding Centers of America dba PCCA 1 Onesource Specialty Pharma Limited 1

…and 8 more on the FDA NDC directory.

Acetylcysteine drug class (RxNorm)

Acetylcysteine belongs to the Antidote class.

Pharmacologic class Antidote, Mucolytic, Antidote for Acetaminophen Overdose
Drug family (ATC) Mucolytics, Other ophthalmologicals, Antidotes
How it works Reduction Activity

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Acetylcysteine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 15, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Acetylcysteine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Acetylcysteine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
7
Finished products in the current FDA directory
85
Companies listing them (makers, repackagers, distributors)
32
Linked representative label ⓘ
Fresenius Kabi USA, LLC
Linked label effective
Aug 15, 2024
Composite sections available
14
Linked SPL Set ID
75b48fab-cef6-465c-a1e0-d085b3988bc4
Linked SPL Document ID
da00a3b4-d7e8-464b-a13f-422b445de8ee
Open the linked representative label on DailyMed ↗

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HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Fresenius Kabi USA, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →