Medicine
Levoleucovorin 50 mg/5 mL powder for injection
Levoleucovorin 50 mg/5 mL powder for injection is a generic prescription medicine for intravenous use, made by 2 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°C to 25°C (68°F to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Levoleucovorin
- Brand
- Sold under the generic name
- Strength
- 50 mg/5 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Manufacturer
- Hikma Pharmaceuticals2 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°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
- 7 July 2016
- Identifiers
- RxCUI 1720760DailyMed set ID 54f01988-aac2-4b0e-9d20-b7f621a0cd50, b4dd0e14-d42a-4581-b1f0-7ba95b50bca6NDC 0143-9558, 71288-104Application ANDA206263, ANDA211003
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial in 1 box / 5 mL in 1 vial | 0143-9558-01 | Hikma Pharmaceuticals | 7 July 2016 |
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 7 March 2008 | 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 Levoleucovorin
Clinical summary
Levoleucovorin is a folate analog indicated for rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma, among other approved uses. It is available as injection and powder for injection for intravenous use. MedsAcross supplies Levoleucovorin 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 LevoleucovorinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- KHAPZORY prescribing information (Acrotech Biopharma) · U.S. National Library of Medicine, DailyMed
Need Levoleucovorin 50 mg/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.