Medicine
Acetadote 6000 mg/30 mL injection
Acetadote 6000 mg/30 mL injection is a prescription medicine containing Acetylcysteine for intravenous use, marketed by Cumberland Pharmaceuticals, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
The diluted solution can be stored for 24 hours at room temperature.
Key facts
- Active ingredient (INN)
- Acetylcysteine
- Brand
- Acetadote
- Strength
- 6000 mg/30 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 4 vials of 30 mL
- Marketing authorisation holder
- Cumberland Pharmaceuticals
- Manufacturer
- Cumberland Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- The diluted solution can be stored for 24 hours at room temperature.
- Cold chain
- Not required on record
- 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
- 23 January 2004
- Identifiers
- RxCUI 465377, 582119DailyMed set ID 472f158a-5ab9-4308-8e49-1116e6ea3d39NDC 66220-207Application NDA021539
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 4 vial in 1 carton / 30 mL in 1 vial | 66220-207-30 | Cumberland Pharmaceuticals | 23 January 2004 |
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 6000 mg/30 mL injection.
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 Acetadote 6000 mg/30 mL injection 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.