Medicine
Acetylcysteine 200 mg/mL inhalant
Acetylcysteine 200 mg/mL inhalant is a generic prescription medicine for inhalation use, made by 2 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store unopened vials at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C…
Key facts
- Active ingredient (INN)
- Acetylcysteine
- Brand
- Sold under the generic name
- Strength
- 200 mg/mL
- Dosage form
- Inhalant
- Route
- Inhalation
- Packs
- 25 vials, 3 vials, 5 vials
- Manufacturers
- American RegentCardinal Health
- Origin register
- US FDA, United States
- Storage
- Store unopened vials at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F). 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.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R05CB01 Acetylcysteine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 October 1995
- Identifiers
- RxCUI 307718, 307719DailyMed set ID f56b4087-db48-4fd7-84ec-9c927962b805, c90fca12-12fb-4cf6-bd6f-83bc0d95df81NDC 0517-7610, 55154-5731, 0517-7604Application ANDA072547
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 vial, glass in 1 tray / 4 mL in 1 vial, glass | 0517-7604-25 | American Regent | 1 October 1995 |
| 3 vial, glass in 1 box / 10 mL in 1 vial, glass | 0517-7610-03 | American Regent | 1 October 1995 |
| 5 vial, glass in 1 bag / 4 mL in 1 vial, glass | 55154-5731-5 | Cardinal Health | 6 May 2011 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 14 September 1963 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Acetylcysteine
Clinical summary
Acetylcysteine is an antidote indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients, among other approved uses. MedsAcross supplies Acetylcysteine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about AcetylcysteineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- acetylcysteine prescribing information (Padagis) · U.S. National Library of Medicine, DailyMed
Need Acetylcysteine 200 mg/mL inhalant for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.