Medicine
Acetylcysteine 6000 mg/30 mL injection
Acetylcysteine 6000 mg/30 mL injection is a generic prescription medicine for intravenous use, made by 10 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store unopened vials at controlled room temperature, 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Acetylcysteine
- Brand
- Sold under the generic name
- Strength
- 6000 mg/30 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 4 vials of 30 mL and 9 more
- Manufacturers
- EugiaIndiaGlenmark PharmaceuticalsIndiaIndoco RemediesIndiaFresenius KabiSagent PharmaceuticalsHikma PharmaceuticalsOnesource Specialty PharmaPadagisSomerset TherapeuticsXellia Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store unopened vials at controlled room temperature, 20° to 25°C (68° to 77°F).
- 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
- 9 November 2012
- Identifiers
- RxCUI 465377DailyMed set ID d990ef51-ced2-4359-b99b-092334d2dc9b, 8cca4e4c-85a2-d575-e053-2995a90a6599, 3e2e187e-2445-43b1-b66c-b828e2adf022 +9NDC 63323-963, 70594-111, 0574-0805 +7Application ANDA200644, ANDA217182, NDA021539 +5
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 |
|---|---|---|---|
| 4 vial, single-dose in 1 carton / 30 mL in 1 vial, single-dose | 55150-259-30 | EugiaIndia | 29 February 2016 |
| 4 vial, single-dose in 1 carton / 30 mL in 1 vial, single-dose | 68462-946-12 | Glenmark PharmaceuticalsIndia | 25 September 2024 |
| 4 vial in 1 carton / 30 mL in 1 vial | 14445-412-04 | Indoco RemediesIndia | 1 March 2022 |
| 4 vial, single-dose in 1 carton / 30 mL in 1 vial, single-dose | 63323-963-30 | Fresenius Kabi | 9 November 2012 |
| 4 vial, single-dose in 1 carton / 30 mL in 1 vial, single-dose | 63323-963-44 | Fresenius Kabi | 9 November 2012 |
| 4 vial in 1 carton / 30 mL in 1 vial | 25021-812-30 | Sagent Pharmaceuticals | 15 April 2018 |
| 4 vial in 1 carton / 30 mL in 1 vial | 25021-812-66 | Sagent Pharmaceuticals | 15 February 2022 |
| 4 vial in 1 carton / 30 mL in 1 vial | 0143-9433-04 | Hikma Pharmaceuticals | 31 March 2026 |
| 4 vial, single-dose in 1 carton / 30 mL in 1 vial, single-dose | 83270-001-04 | Onesource Specialty Pharma | 26 April 2023 |
| 4 vial in 1 carton / 30 mL in 1 vial | 0574-0805-30 | Padagis | 20 December 2012 |
| 4 vial in 1 carton / 30 mL in 1 vial | 70069-788-04 | Somerset Therapeutics | 13 June 2024 |
| 4 vial in 1 carton / 30 mL in 1 vial | 70594-111-02 | Xellia Pharmaceuticals | 10 June 2023 |
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 Acetylcysteine 6000 mg/30 mL injection for your hospital or patient?
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