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Acetylcysteine 200 mg/mL Solution — NDC 63323-0692-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acetylcysteine 200 mg/mL Solution — NDC 63323-692-10 (Billing 63323-0692-10)

by Fresenius Kabi USA, LLC · 3 VIAL in 1 CARTON / 10 mL in 1 VIAL

This is a package of Acetylcysteine 200 mg/mL Solution from Fresenius Kabi USA, LLC, marketed since Sep 2012 and currently FDA-listed; retail pharmacies pay about $1.32 per mL (NADAC). It is this product's only package size.

NDC 63323-0692-10
🏷️ FDA NDC (as labeled) 63323-692-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 63323-692-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 692 product · 10 package
Package marketed since
Sep 1, 2012
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6332369210 0
Medicaid fills, this package
585 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Acetylcysteine (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0797-2026
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0796-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-692-10
Product NDC 63323-692
11-digit billing NDC 63323069210
NCPDP billing unit ML — per mL (volume)
RxCUI 307718, 307719
UNII WYQ7N0BPYC
Application # ANDA203853
SPL Set ID 75b48fab-cef6-465c-a1e0-d085b3988bc4
Established class (EPC) Antidote; Antidote for Acetaminophen Overdose; Mucolytic
Mechanism of action Reduction Activity
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Glutathione Concentration
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-09-01
Route ORAL, RESPIRATORY (INHALATION)
Dosage form SOLUTION
Substance ACETYLCYSTEINE
TE code (Orange Book) AN · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 43300010002005
GPI class Acetylcysteine
GCN Seq No 000592
GCN 02401
HICL code 000189
Ingredient (HICL) Acetylcysteine
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3A
Therapeutic class — specific (HIC3) Mucolytics
AHFS code 48:24.00.00
AHFS class Mucolytic Agents
FDB label name ACETYLCYSTEINE 20% VIAL
FDB brand name Acetylcysteine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000592
  • GCN: 02401
  • GPI-14 (Medi-Span): 43300010002005
  • HICL (First Databank): 000189
  • AHFS class code: 48:24.00.00
  • RxCUI (RxNorm): 307718
Why two NDCs? The FDA registers this code as 63323-692-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63323-0692-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine 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
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ACETYLCYSTEINE 20% VIAL Ingredient Acetylcysteine
📖 What it is MedlinePlus · NLM

Acetylcysteine inhalation is used along with other treatments to relieve chest congestion due to thick or abnormal mucous secretions in people with lung conditions including asthma, emphysema, bronchitis and cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction). Acetylcysteine is in a class of medications called mucolytic agents. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps loosen thick, sticky mucus in your airways. It's used as an add-on treatment for conditions like chronic bronchitis, emphysema, pneumonia, cystic fibrosis and tracheostomy...
  • It's usually breathed in as a mist from a nebulizer, often a few times a day. Follow your prescriber's directions exactly. Clean the nebulizer right after each use so it doesn't cl...
  • Don't mix it unless your clinician tells you to. Some antibiotics like tetracycline and erythromycin lactobionate don't mix with it, and safety of other combinations hasn't been es...
  • Can I mix it with my other nebulizer medicines?
📖 Read our full Acetylcysteine Oral Inhalation guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $1.318 $39.55 / 30 ml
Medicaid paysCMS SDUD · 12 mo $1.26 $37.75 / 30 ml
Medicare drug plans payPart D · Q2 2026 $1.53 $45.97 / 30 ml
Medicare Part B allowsASP · J7608 $7.274 / J7608 unit —
NADAC price history (per mL) — tap or hover for the price & month
Apr 2025 $1.318 $1.318
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)63323-692-10
11-digit billing NDC63323-0692-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7608
DescriptorAcetylcysteine, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per gram
Billing units / pkg6 units
How the units are derivedThis package is 10; the HCPCS unit is 1 GM, so one package = 6 billing units.
Medicare Part B spend (2026 (Q1))$575,237 · 2,256 claims · $254.98 per claim (all NDCs under J7608)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63323-0692-10 You're viewing this Main listing 3 VIAL in 1 CARTON / 10 mL in 1 VIAL 2012-09-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acetylcysteine 200 mg/mL 00409-3308-03 Hospira, 3 vials $0.737 AN Availability likely save 44%
Acetylcysteine 200 mg/mL 63323-0690-30 Fresenius 3 vials $0.737 AN Availability likely save 44%
Acetylcysteine 200 mg/mL 70069-0020-03 Somerset 3 vials $0.737 AN Availability likely save 44%
Acetylcysteine 200 mg/mLthis 63323-0692-10 Fresenius 3 vials $1.318 AN Availability likely —
Acetylcysteine 200 mg/mL 00517-7604-25 American 25 vials $2.245 AN Availability likely +70%
Acetylcysteine 200 mg/mL 42494-0436-25 Cameron 25 vials $2.245 AN Availability likely +70%
Acetylcysteine 200 mg/mL 63323-0694-04 Fresenius 25 vials $2.245 AN Availability likely +70%
Acetylcysteine 200 mg/mL 70069-0019-25 Somerset 25 vials $2.245 AN Availability likely +70%
Acetylcysteine 200 mg/mL 00517-7610-03 American 3 vials — AN FDA listed —
Acetylcysteine 200 mg/mL 55154-5731-05 Cardinal 5 vials — AN FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2012
On the market since
Sep 2012
📍
2026
Currently FDA-listed
14 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderALVOGEN INC
FDA applicationANDA203853 (ANDA)
Labeler code63323
First marketedSep 2012
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 135 words ▾

INDICATIONS AND USAGE: Acetylcysteine Solution, USP is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as: Chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung) Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis) Pulmonary complications of cystic fibrosis Tracheostomy care Pulmonary complications associated with surgery Use during anesthesia Post-traumatic chest conditions Atelectasis due to mucous obstruction Diagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization)

INDICATIONS AND USAGE: Acetylcysteine Solution, USP administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. It is essential to initiate treatment as soon as possible after the overdose and, in any case, within 24 hours of ingestion.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION: General Acetylcysteine is available in rubber stoppered glass vials containing 4, 10, or 30 mL. The 20% solution may be diluted to a lesser concentration with either Sodium Chloride Injection, Sodium Chloride Inhalation Solution, Sterile Water for Injection, or Sterile Water for Inhalation. The 10% solution may be used undiluted.

Acetylcysteine 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 for inhalation, store the remainder in a refrigerator and use 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 (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 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 may also be given through a percutaneous intratracheal catheter.

One to 2 mL of the 20% or 2 to 4 mL of the 10% solution every 1 to 4 hours may then be given by a syringe attached to the catheter. Diagnostic Bronchograms For diagnostic bronchial studies, two or three administrations of 1 to 2 mL of the 20% solution or 2 to 4 mL of the 10% solution should be given by nebulization or by instillation intratracheally, prior to the procedure. Administration of Aerosol Materials Acetylcysteine may be administered using conventional nebulizers made of plastic or glass.

Certain materials used in nebulization equipment react with acetylcysteine. The most reactive of these are certain metals (notably iron and copper) and rubber. Where materials may come into contact with acetylcysteine solution, parts made of the following acceptable materials should be used: glass, plastic, aluminum, anodized aluminum, chromed metal, tantalum, sterling silver, or stainless steel.

Silver may become tarnished after exposure, but this is not harmful to the drug action or to the patient. Nebulizing Gases Compressed tank gas (air) or an air compressor should be used to provide pressure for nebulizing the solution. Oxygen may also be used but should be used with the usual precautions in patients with severe respiratory disease and CO 2 retention.

Apparatus Acetylcysteine is usually administered as fine nebulae and the nebulizer used should be capable of providing optimal quantities of a suitable range of particle sizes. Commercially available nebulizers will produce nebulae of acetylcysteine satisfactory for retention in the respiratory tract. Most of the nebulizers tested will supply a high proportion of the drug solution as particles of less than 10 m… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 28 words ▾

CONTRAINDICATIONS: Acetylcysteine is contraindicated in those patients who are sensitive to it.

CONTRAINDICATIONS: There are no contraindications to oral administration of acetylcysteine in the treatment of acetaminophen overdose.

⚠️ Warnings 167 words ▾

WARNINGS: After proper administration of acetylcysteine, an increased volume of liquified bronchial secretions may occur. When cough is inadequate, the airway must be maintained open by mechanical suction if necessary. When there is a mechanical block due to foreign body or local accumulation, the airway should be cleared by endotracheal aspiration, with or without bronchoscopy.

Asthmatics under treatment with acetylcysteine should be watched carefully. Most patients with bronchospasm are quickly relieved by the use of a bronchodilator given by nebulization. If bronchospasm progresses, the medication should be discontinued immediately.

WARNINGS: Generalized urticaria has been observed rarely in patients receiving oral acetylcysteine for acetaminophen overdose. If this occurs or other allergic symptoms appear, treatment with acetylcysteine should be discontinued unless it is deemed essential and the allergic symptoms can be otherwise controlled. If encephalopathy due to hepatic failure becomes evident, acetylcysteine treatment should be discontinued to avoid further administration of nitrogenous substances.

There are no data indicating that acetylcysteine influences hepatic failure, but this remains a theoretical possibility.

🤒 Adverse Reactions 153 words ▾

ADVERSE REACTIONS: Adverse effects have included stomatitis, nausea, vomiting, fever, rhinorrhea, drowsiness, clamminess, chest tightness, and bronchoconstriction. Clinically overt acetylcysteine induced bronchospasm occurs infrequently and unpredictably even in patients with asthmatic bronchitis or bronchitis complicating bronchial asthma. Acquired sensitization to acetylcysteine has been reported rarely.

Reports of sensitization in patients have not been confirmed by patch testing. Sensitization has been confirmed in several inhalation therapists who reported a history of dermal eruptions after frequent and extended exposure to acetylcysteine. Reports of irritation to the tracheal and bronchial tracts have been received and although hemoptysis has occurred in patients receiving acetylcysteine such findings are not uncommon in patients with bronchopulmonary disease and a causal relationship has not been established.

ADVERSE REACTIONS: Oral administration of acetylcysteine, especially in the large doses needed to treat acetaminophen overdose, may result in nausea, vomiting and other gastrointestinal symptoms. Rash with or without mild fever has been observed rarely.

🔄 Drug Interactions 20 words ▾

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

🤰 Pregnancy ~1 min read ▾

Pregnancy Teratogenic Effects: Pregnancy Category B In a teratology study of acetylcysteine in the rabbit, oral doses of 500 mg/kg/day (2.6 times the human mucolytic dose) were administered to pregnant does by intubation on days 6 through 16 of gestation. Acetylcysteine was found to be nonteratogenic under the conditions of the study. In the rabbit, two groups (one of 14 and one of 16 pregnant females) were exposed to an aerosol of 10% acetylcysteine and 0.05% isoproterenol hydrochloride for 30 and 35 minutes twice a day from the 6th through the 18th day of pregnancy.

No teratogenic effects were observed among the offspring. Teratology and a perinatal or postnatal toxicity study in rats were performed with a combination of acetylcysteine and isoproterenol administered by the inhalation route. In the rat, two groups of 25 pregnant females each were exposed to the aerosol for 30 and 35 minutes, respectively, twice a day from the 6th through the 15th day of gestation.

No teratogenic effects were observed among the offspring. In the pregnant rat (30 rats per group), twice-daily exposure to an aerosol of acetylcysteine and isoproterenol for 30 or 35 minutes from the 15th day of gestation through the 21st day postpartum was without adverse effect on dams or newborns. Reproduction studies of acetylcysteine with isoproterenol have been performed in rats and of acetylcysteine alone in rabbits at doses up to 2.6 times the human dose.

These have revealed no evidence of impaired fertility or harm to the fetus due to acetylcysteine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies may not always be predictive of human responses, this drug should be used during pregnancy only if clearly needed.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY: The viscosity of pulmonary mucous secretions depends on the concentrations of mucoprotein and, to a lesser extent, deoxyribonucleic acid (DNA). The latter increases with increasing purulence owing to the presence of cellular debris. The mucolytic action of acetylcysteine is related to the sulfhydryl group in the molecule.

This group probably “opens” disulfide linkages in mucus thereby lowering the viscosity. The mucolytic activity of acetylcysteine is unaltered by the presence of DNA, and increases with increasing pH. Significant mucolysis occurs between pH 7 and 9.

Acetylcysteine undergoes rapid deacetylation in vivo to yield cysteine or oxidation to yield diacetylcystine. Occasionally, patients exposed to the inhalation of an acetylcysteine aerosol respond with the development of increased airways obstruction of varying and unpredictable severity. Those patients who are reactors cannot be identified a priori from a random patient population.

Even when patients are known to have reacted previously to the inhalation of an acetylcysteine aerosol, they may not react during a subsequent treatment. The converse is also true; patients who have had inhalation treatments of acetylcysteine without incident may still react to subsequent inhalation with increased airways obstruction. Most patients with bronchospasm are quickly relieved by the use of a bronchodilator given by nebulization.

If bronchospasm progresses, the medication should be discontinued immediately.

ACETYLCYSTEINE AS AN ANTIDOTE FOR ACETAMINOPHEN OVERDOSE CLINICAL PHARMACOLOGY: (Antidotal) Acetaminophen is rapidly absorbed from the upper gastrointestinal tract with peak plasma levels occurring between 30 and 60 minutes after therapeutic doses and usually within 4 hours following an overdose. The parent compound, which is nontoxic, is extensively metabolized in the liver to form principally the sulfate and glucuronide conjugates which are also nontoxic and are rapidly excreted in the urine. A small fraction of an ingested dose is metabolized in the liver by the cytochrome P-450 mixed function oxidase enzyme system to form a reactive, potentially toxic, intermediate metabolite which preferentially conjugates with hepatic glutathione to form the nontoxic cysteine and mercapturic acid derivatives which are then excreted by the kidney.

Therapeutic doses of acetaminophen do not saturate the glucuronide and sulfate conjugation pathways and do not result in the formation of sufficient reactive metabolite to deplete glutathione stores. However, following ingestion of a large overdose (150 mg/kg or greater) the glucuronide and sulfate conjugation pathways are saturated resulting in a larger fraction of the drug being metabolized via the P-450 pathway. The increased formation of reactive metabolite may deplete the hepatic stores of glutathione with subsequent binding of the metabolite to protein molecules within the hepatocyte resulting in cellular necrosis.

Acetylcysteine has been shown to reduce the extent of liver injury following acetaminophen overdose. Its effectiveness depends on early oral administration, with benefit seen principally in patients treated within 16 hours of the overdose. Acetylcysteine probably protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite.

📦 How Supplied / Storage and Handling ~1 min read ▾

HOW SUPPLIED Acetylcysteine Solution, USP is available in rubber stoppered glass vials containing 4, 10, 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 is sterile, not for injection and can be used for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). It is available as follows: Acetylcysteine 10% solution (100 mg acetylcysteine per mL). Sterile, not for injection.

Product No. NDC No. Strength 695104 63323-695-04 10% (100 mg/mL) 4 mL 5 mL vials packed in carton of twenty five 693110 63323-693-10 10% (100 mg/mL) 10 mL 10 mL vials packed in carton of three, plastic dropper 691130 63323-691-30 10% (100 mg/mL) 30 mL 30 mL vials packed in carton of three Acetylcysteine 20% solution (200 mg acetylcysteine per mL).

Sterile, not for injection. Product No. NDC No.

Strength 694104 63323-694-04 20% (200 mg/mL) 4 mL 5 mL vials packed in carton of twenty five 692110 63323-692-10 20% (200 mg/mL) 10 mL 10 mL vials packed in carton of three, plastic dropper 690130 63323-690-30 20% (200 mg/mL) 30 mL 30 mL vials packed in carton of three STORAGE: Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (see USP Controlled Room Temperature). Store in refrigerator 2° - 8°C (36° - 46°F) after opening. Acetylcysteine does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution.

Dilutions of acetylcysteine should be used freshly prepared and utilized within one hour. If only a portion of the solution in a vial is used, store the remaining undiluted portion in a refrigerator and use within 96 hours.

📋 Description 125 words ▾

DESCRIPTION: Acetylcysteine Solution, USP is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solution (NOT FOR INJECTION). The solutions contain 20% (200 mg/mL) or 10% (100 mg/mL) acetylcysteine, with disodium edetate in purified water. Sodium hydroxide and/or hydrochloric acid is added to adjust pH (range 6.0 to 7.5).

Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, cysteine. The compound is a white crystalline powder with the molecular formula C 5 H 9 NO 3 S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula: This product contains the following inactive ingredients: disodium edetate, sodium hydroxide, purified water, and hydrochloric acid, if necessary.

ACETYLCYSTEINE AS A MUCOLYTIC AGENT structural formula acetylcysteine

⚠️ Precautions ~3 min read ▾

PRECAUTIONS: General With the administration of acetylcysteine, the patient may observe initially a slight disagreeable odor that is soon not noticeable. With a face mask there may be stickiness on the face after nebulization. This is easily removed by washing with water.

Under certain conditions, a color change may occur in acetylcysteine in the opened bottle. The light purple color is the result of a chemical reaction which does not significantly affect the safety or mucolytic effectiveness of acetylcysteine. Continued nebulization of acetylcysteine solution with a dry gas will result in an increased concentration of the drug in the nebulizer because of evaporation of the solvent.

Extreme concentration may impede nebulization and efficient delivery of the drug. Dilution of the nebulizing solution with appropriate amounts of Sterile Water for Injection, USP, as concentration occurs, will obviate this problem. Drug Interactions Drug stability and safety of acetylcysteine when mixed with other drugs in a nebulizer have not been established.

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies in laboratory animals have not been performed with acetylcysteine alone, nor with acetylcysteine in combination with isoproterenol. Long-term oral studies of acetylcysteine alone in rats (12 months of treatment followed by 6 months of observation) at doses up to 1,000 mg/kg/day (5.2 times the human mucolytic dose) provided no evidence of oncogenic activity. Mutagenesis Published data 1 indicate that acetylcysteine is not mutagenic in the Ames test, both with and without metabolic activation.

Impairment of Fertility A reproductive toxicity test to assess potential impairment of fertility was performed with acetylcysteine (10%) combined with isoproterenol (0.05%) and administered as an aerosol into a chamber of 12.43 cubic meters. The combination was administered for 25, 30, or 35 minutes twice a day for 68 days before mating, to 200 male and 150 female rats; no adverse effects were noted in dams or pups. Females after mating were continued on treatment for the next 42 days.

Reproductive toxicity studies of acetylcysteine in the rat given oral doses of acetylcysteine up to 1,000 mg/kg (5.2 times the human mucolytic dose) have also been reported in the literature. 1 The only adverse effect observed was a slight non-dose-related reduction in fertility at dose levels of 500 or 1,000 mg/kg/day (2.6 or 5.2 times the human mucolytic dose) in the Segment I study. Pregnancy Teratogenic Effects: Pregnancy Category B In a teratology study of acetylcysteine in the rabbit, oral doses of 500 mg/kg/day (2.6 times the human mucolytic dose) were administered to pregnant does by intubation on days 6 through 16 of gestation.

Acetylcysteine was found to be nonteratogenic under the conditions of the study. In the rabbit, two groups (one of 14 and one of 16 pregnant females) were exposed to an aerosol of 10% acetylcysteine and 0.05% isoproterenol hydrochloride for 30 and 35 minutes twice a day from the 6th through the 18th day of pregnancy. No teratogenic effects were observed among the offspring.

Teratology and a perinatal or postnatal toxicity study in rats were performed with a combination of acetylcysteine and isoproterenol administered by the inhalation route. In the rat, two groups of 25 pregnant females each were exposed to the aerosol for 30 and 35 minutes, respectively, twice a day from the 6th through the 15th day of gestation. No teratogenic effects were observed among the offspring.

In the pregnant rat (30 rats per group), twice-daily exposure to an aerosol of acetylcysteine and isoproterenol for 30 or 35 minutes from the 15th day of gestation through the 21st day postpartum was without adverse effect on dams or newborns. Reproduction studies of acetylcysteine with isoproterenol have been performed in rats and of acetylcysteine alone in rabbits at doses up to 2.6 times the human dose. These have revealed no evid… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 34 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when acetylcysteine is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies in laboratory animals have not been performed with acetylcysteine alone, nor with acetylcysteine in combination with isoproterenol. Long-term oral studies of acetylcysteine alone in rats (12 months of treatment followed by 6 months of observation) at doses up to 1,000 mg/kg/day (5.2 times the human mucolytic dose) provided no evidence of oncogenic activity. Mutagenesis Published data 1 indicate that acetylcysteine is not mutagenic in the Ames test, both with and without metabolic activation.

Impairment of Fertility A reproductive toxicity test to assess potential impairment of fertility was performed with acetylcysteine (10%) combined with isoproterenol (0.05%) and administered as an aerosol into a chamber of 12.43 cubic meters. The combination was administered for 25, 30, or 35 minutes twice a day for 68 days before mating, to 200 male and 150 female rats; no adverse effects were noted in dams or pups. Females after mating were continued on treatment for the next 42 days.

Reproductive toxicity studies of acetylcysteine in the rat given oral doses of acetylcysteine up to 1,000 mg/kg (5.2 times the human mucolytic dose) have also been reported in the literature. 1 The only adverse effect observed was a slight non-dose-related reduction in fertility at dose levels of 500 or 1,000 mg/kg/day (2.6 or 5.2 times the human mucolytic dose) in the Segment I study.

📚 References 29 words ▾

REFERENCES: Bonanomi L, Gazzaniga A. Toxicological, pharmacokinetic and metabolic studies on acetylcysteine. Eur J Respir Dis , 1981; 61 (Suppl III): 45-51. Am Rev Respir Dis , 1960; 82:627−639.

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL – 4 mL (10%) Tray Label NDC 63323- 695 -04 695104 ACETYLCYSTEINE SOLUTION, USP 10% (100 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION. PRESERVATIVE FREE 25 x 4 mL Vials Rx only PRINCIPAL DISPLAY PANEL – 4 mL (10%) Tray Label

PRINCIPAL DISPLAY PANEL – 4 mL (10%) Vial Label NDC 63323- 695 -22 695104 ACETYLCYSTEINE SOLUTION, USP 10% (100 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION. PRESERVATIVE FREE 4 mL Vial Rx only PRINCIPAL DISPLAY PANEL – 4 mL (10%) Vial Label

PRINCIPAL DISPLAY PANEL – 10 mL (10%) Tray Label NDC 63323- 693 -10 693110 ACETYLCYSTEINE SOLUTION, USP 10% (100 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION. PRESERVATIVE FREE 3 x 10 mL Vials Rx only PRINCIPAL DISPLAY PANEL – 10 mL (10%) Tray Label

PRINCIPAL DISPLAY PANEL – 10 mL (10%) Vial Label NDC 63323- 693 -22 693110 ACETYLCYSTEINE SOLUTION, USP 10% (100 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION. PRESERVATIVE FREE 10 mL Vial Rx only PRINCIPAL DISPLAY PANEL – 10 mL (10%) Vial Label

PRINCIPAL DISPLAY PANEL – 30 mL (10%) Tray Label NDC 63323- 691 -30 691130 ACETYLCYSTEINE SOLUTION, USP 10% (100 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION. PRESERVATIVE FREE 3 x 30 mL Vials Rx only PRINCIPAL DISPLAY PANEL – 30 mL (10%) Tray Label

PRINCIPAL DISPLAY PANEL – 30 mL (10%) Vial Label NDC 63323- 691 -22 691130 ACETYLCYSTEINE SOLUTION, USP 10% (100 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION. PRESERVATIVE FREE 30 mL Vial Rx only PRINCIPAL DISPLAY PANEL – 30 mL (10%) Vial Label

PRINCIPAL DISPLAY PANEL – 4 mL (20%) Tray Label NDC 63323- 694 -04 694104 ACETYLCYSTEINE SOLUTION, USP 20% (200 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION. PRESERVATIVE FREE 25 x 4 mL Vials Rx only PRINCIPAL DISPLAY PANEL – 4 mL (20%) Tray Label

PRINCIPAL DISPLAY PANEL – 4 mL (20%) Vial Label NDC 63323- 694 -22 694104 ACETYLCYSTEINE SOLUTION, USP 20% (200 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION. PRESERVATIVE FREE 4 mL Vial Rx only PRINCIPAL DISPLAY PANEL – 4 mL (20%) Vial Label

PRINCIPAL DISPLAY PANEL – 10 mL (20%) Tray Label NDC 63323- 692 -10 692110 ACETYLCYSTEINE SOLUTION, USP 20% (200 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION. PRESERVATIVE FREE 3 x 10 mL Vials Rx only PRINCIPAL DISPLAY PANEL – 10 mL (20%) Tray Label

PRINCIPAL DISPLAY PANEL – 10 mL (20%) Vial Label NDC 63323- 692 -22 692110 ACETYLCYSTEINE SOLUTION, USP 20% (200 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION. PRESERVATIVE FREE 10 mL Vial Rx only PRINCIPAL DISPLAY PANEL – 10 mL (20%) Vial Label

PRINCIPAL DISPLAY PANEL – 30 mL (20%) Tray Label NDC 63323- 690 -30 690130 ACETYLCYSTEINE SOLUTION, USP 20% (200 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION. PRESERVATIVE FREE 3 x 30 mL Vials Rx only PRINCIPAL DISPLAY PANEL – 30 mL (20%) Tray Label

PRINCIPAL DISPLAY PANEL – 30 mL (20%) Vial Label NDC 63323- 690 -22 690130 ACETYLCYSTEINE SOLUTION, USP 20% (200 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION. PRESERVATIVE FREE 30 mL Vial Rx only PRINCIPAL DISPLAY PANEL – 30 mL (20%) Vial Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
585
Units reimbursed last 4 qtrs
53.8K
Gross reimbursed last 4 qtrs
$67.7K
Avg / prescription
$115.78
Avg / unit
$1.2583
Latest quarter Q1 2026
152Rx
Medicaid pays / mL
$1.2583
gross reimbursed
vs
NADAC / mL
$1.3184
acquisition cost
=
Spread
−$0.0601
-5% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
26% FFS 74% MCO
Fee-for-service · 155 Rx Managed care · 430 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 570 units · 9.6 per 100k residents WI Michigan: no data reported MI New York: 2,020 units · 10.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,560 units · 12.4 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 9,340 units · 101 per 100k residents NJ Massachusetts: no data reported MA California: 12,972 units · 33.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 1,060 units · 12.2 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 1,920 units · 25.8 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 20,605 units · 67.6 per 100k residents TX Florida: 3,780 units · 16.7 per 100k residents FL
Units reimbursed · per 100k residents
9.6101
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Jersey 101 /100k
2 Texas 67.6 /100k
3 California 33.3 /100k
4 Arizona 25.8 /100k
5 Florida 16.7 /100k
6 Illinois 12.4 /100k
7 Virginia 12.2 /100k
8 New York 10.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Acetylcysteine — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acetylcysteine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$696.9K
Claims incl. refills
6.4K
Beneficiaries
2.6K
Spend / beneficiary
$269.81
Spend / claim
$108.17
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 63323-0691-30 · Fresenius 63323-0693-10 · Fresenius →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.