Medicine
Fomepizole 1.5 g/1.5 mL injection
Fomepizole 1.5 g/1.5 mL injection is a generic prescription medicine for intravenous use, made by 6 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 at controlled room temperature, 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Fomepizole
- Brand
- Sold under the generic name
- Strength
- 1.5 g/1.5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 1.5 mL and 4 more
- Manufacturers
- Gland PharmaIndiaZydus LifesciencesIndiaAmerican RegentMylan InstitutionalNavintaSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store 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
- V03AB34 Fomepizole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 October 2012
- Identifiers
- RxCUI 310414DailyMed set ID 6fed6052-f159-46d6-8be1-31e18a7ba918, a31d0148-2729-49de-b666-f24b0dfd2401, 1dea37fd-ec17-416e-b28e-980a87d49e1a +4NDC 68475-510, 0517-0710, 25021-829 +3Application ANDA078537, ANDA078368, ANDA216791 +1
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 |
|---|---|---|---|
| 1 vial in 1 carton / 1.5 mL in 1 vial | 68083-510-01 | Gland PharmaIndia | 6 July 2023 |
| 1 vial in 1 carton / 1.5 mL in 1 vial | 70710-1478-1 | Zydus LifesciencesIndia | 18 March 2021 |
| 1 vial in 1 carton / 1.5 mL in 1 vial | 0517-0710-01 | American Regent | 16 July 2018 |
| 1 vial in 1 carton / 1.5 mL in 1 vial | 0517-0710-88 | American Regent | 31 July 2020 |
| 1 vial, glass in 1 carton / 1.5 mL in 1 vial, glass | 67457-211-02 | Mylan Institutional | 9 October 2012 |
| 1 vial in 1 carton / 1.5 mL in 1 vial | 68475-510-01 | Navinta | 2 April 2021 |
| 1 vial in 1 carton / 1.5 mL in 1 vial | 25021-829-02 | Sagent Pharmaceuticals | 15 November 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 4 December 1997 | 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
Clinical summary
Fomepizole is an antidote indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis. MedsAcross supplies Fomepizole 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 FomepizoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Fomepizole prescribing information (Zydus Lifesciences) · U.S. National Library of Medicine, DailyMed
Need Fomepizole 1.5 g/1.5 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.