Medicine
Decitabine 50 mg/20 mL powder for injection
Decitabine 50 mg/20 mL powder for injection is a generic prescription medicine for intravenous use, made by 8 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 vials at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C…
Key facts
- Active ingredient (INN)
- Decitabine
- Brand
- Sold under the generic name
- Strength
- 50 mg/20 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial and 6 more
- Manufacturers
- Accord HealthcareIndiaMeitheal PharmaceuticalsAmneal PharmaceuticalsBluePoint LaboratoriesMylan InstitutionalNivagen PharmaceuticalsQilu PharmaceuticalSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store vials at 20°C to 25°C (68°F to 77°F), excursions permitted between 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
- L01BC08 Decitabine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 March 2017
- Identifiers
- RxCUI 636631DailyMed set ID 150537a8-10ac-422d-bf33-68b1a408e566, 40e7ef72-8df5-4adf-a269-4ae1c26eb6f9, b46df7d7-d98e-4c7e-b1ee-e03e258781c4 +6NDC 75834-190, 70121-1644, 16729-224 +5Application ANDA212117, ANDA206033, ANDA203475 +3
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 / 20 mL in 1 vial | 16729-224-05 | Accord HealthcareIndia | 8 March 2017 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 71288-119-20 | Meitheal Pharmaceuticals | 2 July 2021 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 71288-119-91 | Meitheal Pharmaceuticals | 2 July 2021 |
| 1 vial, single-use in 1 carton / 20 mL in 1 vial, single-use | 70121-1644-1 | Amneal Pharmaceuticals | 1 December 2019 |
| 1 vial in 1 carton / 20 mL in 1 vial | 67457-316-25 | Mylan Institutional | 10 October 2018 |
| 1 vial in 1 carton / 20 mL in 1 vial | 75834-190-01 | Nivagen Pharmaceuticals | 17 December 2020 |
| 1 vial in 1 carton / 20 mL in 1 vial | 67184-0535-1 | Qilu Pharmaceutical | 12 April 2021 |
| 1 vial in 1 carton / 20 mL in 1 vial | 25021-219-20 | Sagent Pharmaceuticals | 1 November 2023 |
| 1 vial in 1 carton / 20 mL in 1 vial | 68001-618-37 | BluePoint Laboratories | 3 May 2024 |
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
Other strengths and forms of Decitabine
Clinical summary
Decitabine is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, among other approved uses. It is available as powder for injection and kits for intravenous use. MedsAcross supplies Decitabine 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 DecitabineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- decitabine prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
- Dacogen: European public assessment report (EPAR) · European Medicines Agency
Need Decitabine 50 mg/20 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.