Medicine
Nelarabine 250 mg/50 mL injection
Nelarabine 250 mg/50 mL injection is a generic prescription medicine for intravenous use, made by 10 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 nelarabine injection between 20°C and 25°C (68°F and 77°F), excursions…
Key facts
- Active ingredient (INN)
- Nelarabine
- Brand
- Sold under the generic name
- Strength
- 250 mg/50 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 50 mL, 6 vials of 50 mL and 21 more
- Manufacturers
- Zydus LifesciencesIndiaAlembic PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaNovadoz PharmaceuticalsIndiaGland PharmaIndiaAmneal PharmaceuticalsSagent PharmaceuticalsShorla OncologyXGen Pharmaceuticals DJBMeitheal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store nelarabine injection between 20°C and 25°C (68°F and 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01BB07 Nelarabine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 November 2021
- Identifiers
- RxCUI 603566, 2722411DailyMed set ID 57275b05-f40f-7298-5a5e-93594bc41437, fc401b06-4e3b-413e-a854-3e031c433862, 877b69a0-0899-455d-926e-f5a7478c31f8 +10NDC 43598-142, 81927-111, 70771-1685 +10Application ANDA216934, ANDA214809, ANDA215037 +6
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, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 70710-1726-1 | Zydus LifesciencesIndia | 17 November 2021 |
| 6 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 70710-1726-8 | Zydus LifesciencesIndia | 17 November 2021 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 70710-1839-1 | Zydus LifesciencesIndia | 24 June 2022 |
| 6 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 70710-1839-8 | Zydus LifesciencesIndia | 24 June 2022 |
| 1 vial in 1 carton / 50 mL in 1 vial | 70771-1685-1 | Zydus LifesciencesIndia | 17 November 2021 |
| 6 vial in 1 carton / 50 mL in 1 vial | 70771-1685-8 | Zydus LifesciencesIndia | 17 November 2021 |
| 1 vial in 1 carton / 50 mL in 1 vial | 46708-813-50 | Alembic PharmaceuticalsIndia | 1 August 2024 |
| 6 vial in 1 carton / 50 mL in 1 vial | 46708-813-63 | Alembic PharmaceuticalsIndia | 1 August 2024 |
| 1 vial in 1 carton / 50 mL in 1 vial | 62332-813-50 | Alembic PharmaceuticalsIndia | 1 August 2024 |
| 6 vial in 1 carton / 50 mL in 1 vial | 62332-813-63 | Alembic PharmaceuticalsIndia | 1 August 2024 |
| 6 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 43598-142-06 | Dr. Reddy's LaboratoriesIndia | 9 January 2023 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 43598-142-11 | Dr. Reddy's LaboratoriesIndia | 1 March 2023 |
| 6 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 68083-233-06 | Gland PharmaIndia | 3 January 2024 |
| 1 vial in 1 carton / 50 mL in 1 vial | 72205-154-01 | Novadoz PharmaceuticalsIndia | 22 October 2024 |
| 6 vial in 1 carton / 50 mL in 1 vial | 72205-154-04 | Novadoz PharmaceuticalsIndia | 22 October 2024 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 70121-1743-1 | Amneal Pharmaceuticals | 18 November 2025 |
| 6 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 70121-1743-4 | Amneal Pharmaceuticals | 10 April 2023 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 71288-165-54 | Meitheal Pharmaceuticals | 10 January 2023 |
| 1 vial in 1 carton / 50 mL in 1 vial | 25021-259-50 | Sagent Pharmaceuticals | 1 August 2024 |
| 6 vial in 1 carton / 50 mL in 1 vial | 25021-259-51 | Sagent Pharmaceuticals | 1 August 2024 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 81927-111-01 | Shorla Oncology | 15 March 2023 |
| 6 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 81927-111-06 | Shorla Oncology | 15 March 2023 |
| 1 vial in 1 carton / 50 mL in 1 vial | 39822-0650-1 | XGen Pharmaceuticals DJB | 17 February 2025 |
| 6 vial in 1 carton / 50 mL in 1 vial | 39822-0650-6 | XGen Pharmaceuticals DJB | 17 February 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
Alternatives
Other makers and brands of Nelarabine 250 mg/50 mL injection.
Other strengths and forms of Nelarabine
Clinical summary
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older, among other approved uses. MedsAcross supplies Nelarabine 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 NelarabineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Arranon prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
- Atriance: European public assessment report (EPAR) · European Medicines Agency
Need Nelarabine 250 mg/50 mL injection for your hospital or patient?
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