Medicine
Leucovorin 5 mg tablet
Leucovorin 5 mg tablet is a generic prescription medicine for oral 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 20° to 25°C (68° to 77°F). Protect from light and moisture.
Key facts
- Active ingredient (INN)
- Leucovorin
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 5 blister pack and 14 more
- Manufacturers
- Proficient RxHikma PharmaceuticalsEpic PharmaIngenus PharmaceuticalsLeading PharmaTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light and moisture.
- 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
- 30 June 1990
- Identifiers
- RxCUI 197860, 197861, 197862 +1DailyMed set ID 33663425-4731-4977-9127-9e59b6b91497, 7409cdee-9093-47af-a4c4-2c55ce1b6361, 46d12bd0-ec7d-4e2c-aeed-b8aa88e6dc5c +3NDC 0054-4496, 50742-181, 71205-908 +4Application ANDA072733, ANDA211132, ANDA213929 +2
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 |
|---|---|---|---|
| 30 tablet in 1 bottle | 0054-4496-13 | Hikma Pharmaceuticals | 22 March 1993 |
| 100 tablet in 1 bottle | 0054-4496-25 | Hikma Pharmaceuticals | 22 March 1993 |
| 5 blister pack in 1 carton / 10 tablet in 1 blister pack | 0054-8496-19 | Hikma Pharmaceuticals | 22 March 1993 |
| 100 tablet in 1 bottle | 42806-358-01 | Epic Pharma | 16 April 2020 |
| 30 tablet in 1 bottle | 42806-358-30 | Epic Pharma | 16 April 2020 |
| 100 tablet in 1 bottle | 50742-181-01 | Ingenus Pharmaceuticals | 30 July 2020 |
| 30 tablet in 1 bottle | 50742-181-30 | Ingenus Pharmaceuticals | 30 July 2020 |
| 100 tablet in 1 bottle | 69315-184-01 | Leading Pharma | 16 November 2020 |
| 30 tablet in 1 bottle | 69315-184-03 | Leading Pharma | 16 November 2020 |
| 30 tablet in 1 bottle | 0555-0484-01 | Teva Pharmaceuticals | 30 June 1990 |
| 100 tablet in 1 bottle | 0555-0484-02 | Teva Pharmaceuticals | 30 June 1990 |
| 100 tablet in 1 bottle | 71205-908-00 | Proficient Rx | 16 July 2021 |
| 1000 tablet in 1 bottle | 71205-908-11 | Proficient Rx | 16 July 2021 |
| 30 tablet in 1 bottle | 71205-908-30 | Proficient Rx | 16 July 2021 |
| 500 tablet in 1 bottle | 71205-908-55 | Proficient Rx | 16 July 2021 |
| 60 tablet in 1 bottle | 71205-908-60 | Proficient Rx | 16 July 2021 |
| 90 tablet in 1 bottle | 71205-908-90 | Proficient Rx | 16 July 2021 |
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 5 mg tablet 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.