Medicine
Edaravone 30 mg/100 mL injection
Edaravone 30 mg/100 mL injection is a generic prescription medicine for intravenous use, made by 3 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 edaravone injection at 20º to 25ºC (68º to 77ºF), excursions permitted…
Key facts
- Active ingredient (INN)
- Edaravone
- Brand
- Sold under the generic name
- Strength
- 30 mg/100 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 2 pouches of 100 mL, 2 bags of 100 mL
- Manufacturers
- Gland PharmaIndiaPiramal Critical CareIndiaSandoz
- Origin register
- US FDA, United States
- Storage
- Store edaravone injection at 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Store in overwrapped package to protect from oxygen degradation until time of use.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07XX14 Edaravone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 May 2024
- Identifiers
- RxCUI 1924316, 2681044DailyMed set ID ae940bc6-1e6a-4b76-825c-bd2e1925e39a, 19862ae9-d6e1-70e6-e063-6394a90ae749, 46452eb5-db17-400d-b25b-11844a11e711NDC 0781-3527, 66794-259, 68083-500Application ANDA216902, ANDA216199
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 |
|---|---|---|---|
| 2 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 68083-500-02 | Gland PharmaIndia | 6 May 2024 |
| 2 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 66794-259-64 | Piramal Critical CareIndia | 8 July 2024 |
| 2 bag in 1 carton / 100 mL in 1 bag | 0781-3527-20 | Sandoz | 21 January 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.
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 Edaravone
Clinical summary
Edaravone is a prescription medicine indicated for the treatment of amyotrophic lateral sclerosis (ALS). It is available as injection and kits for intravenous use. MedsAcross supplies Edaravone 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 EdaravoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- RADICAVA ORS prescribing information (Shionogi) · U.S. National Library of Medicine, DailyMed
Need Edaravone 30 mg/100 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.