Medicine
Acetylcysteine 100 mg/mL inhalation solution
Acetylcysteine 100 mg/mL inhalation solution is a generic prescription medicine for inhalation, oral 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 at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F)…
Key facts
- Active ingredient (INN)
- Acetylcysteine
- Brand
- Sold under the generic name
- Strength
- 100 mg/mL
- Dosage form
- Inhalation solution
- Route
- Inhalation, oral
- Packs
- 3 vials, 25 vials and 1 more
- Manufacturers
- Fresenius KabiHospira
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F). Store in refrigerator 2° - 8°C (36° - 46°F) after opening. 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
- 30 April 2005
- Identifiers
- RxCUI 307718, 307719DailyMed set ID 75b48fab-cef6-465c-a1e0-d085b3988bc4, 5558a5f5-e821-473b-7d8a-5d33d09f0586NDC 63323-691, 63323-693, 63323-695 +1Application ANDA204674, ANDA073664
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 |
|---|---|---|---|
| 3 vial in 1 carton / 30 mL in 1 vial | 63323-691-30 | Fresenius Kabi | 31 March 2014 |
| 3 vial in 1 carton / 10 mL in 1 vial | 63323-693-10 | Fresenius Kabi | 31 March 2014 |
| 25 vial in 1 carton / 4 mL in 1 vial | 63323-695-04 | Fresenius Kabi | 31 March 2014 |
| 3 vial in 1 carton / 30 mL in 1 vial | 0409-3307-03 | Hospira | 30 April 2005 |
| 25 vial in 1 carton / 4 mL in 1 vial | 42494-435-25 | — | 21 August 2025 |
| 25 vial in 1 carton / 4 mL in 1 vial | 70069-018-25 | — | 4 March 2025 |
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
Alternatives
Other makers and brands of Acetylcysteine 100 mg/mL inhalation solution.
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 100 mg/mL inhalation solution 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.