Medicine
Leucovorin 350 mg/17.5 mL powder for injection
Leucovorin 350 mg/17.5 mL powder for injection is a generic prescription medicine for intramuscular, 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 dry product and reconstituted solution at 20° to 25°C (68° to 77°F)…
Key facts
- Active ingredient (INN)
- Leucovorin
- Brand
- Sold under the generic name
- Strength
- 350 mg/17.5 mL
- Dosage form
- Powder for injection
- Route
- Intramuscular, intravenous
- Packs
- 1 vial and 4 more
- Manufacturers
- Gland PharmaIndiaGlenmark PharmaceuticalsIndiaBluePoint LaboratoriesHikma PharmaceuticalsMeitheal PharmaceuticalsSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store dry product and reconstituted solution at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 April 2000
- Identifiers
- RxCUI 237788, 1803930, 1803932 +2DailyMed set ID 9d0e5356-ff39-4a8e-944c-e808a21ef4b2, e9b47126-8b52-43ff-85c4-33d32b3d8326, 79d023ab-7d77-48c1-8f47-ea322fd58c2b +4NDC 25021-816, 68001-418, 68462-767 +4Application ANDA200855, ANDA040335, ANDA218200 +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 / 17.5 mL in 1 vial | 68083-587-01 | Gland PharmaIndia | 12 November 2025 |
| 1 vial in 1 carton / 17.5 mL in 1 vial | 68462-767-35 | Glenmark PharmaceuticalsIndia | 12 November 2025 |
| 1 vial in 1 box, unit-dose / 17.5 mL in 1 vial | 0143-9552-01 | Hikma Pharmaceuticals | 20 April 2000 |
| 1 vial, single-dose in 1 carton / 17.5 mL in 1 vial, single-dose | 71288-163-30 | Meitheal Pharmaceuticals | 19 July 2023 |
| 1 vial in 1 carton / 17.5 mL in 1 vial | 25021-816-30 | Sagent Pharmaceuticals | 15 September 2012 |
| 1 vial in 1 box, unit-dose / 17.5 mL in 1 vial | 68001-418-38 | BluePoint Laboratories | 26 September 2019 |
| 1 vial, single-dose in 1 carton / 17.5 mL in 1 vial, single-dose | 68001-650-38 | BluePoint Laboratories | 15 August 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 20 June 1952 | 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
Other strengths and forms of Leucovorin
Clinical summary
Leucovorin is a folate analog indicated for rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients, among other approved uses. MedsAcross supplies Leucovorin 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 LeucovorinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VYKOURA prescribing information (Avyxa Pharma) · U.S. National Library of Medicine, DailyMed
Need Leucovorin 350 mg/17.5 mL powder for 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.