Medicine
Azacitidine 100 mg/30 mL powder for injection
Azacitidine 100 mg/30 mL powder for injection is a generic prescription medicine for intravenous, subcutaneous use, 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 unreconstituted vials at 25º C (77º F), excursions permitted to 15º-30º…
Key facts
- Active ingredient (INN)
- Azacitidine
- Brand
- Sold under the generic name
- Strength
- 100 mg/30 mL
- Dosage form
- Powder for injection
- Route
- Intravenous, subcutaneous
- Packs
- 1 vial
- Manufacturer
- Fresenius Kabi
- Origin register
- US FDA, United States
- Storage
- Store unreconstituted vials at 25º C (77º F), excursions permitted to 15º-30º C (59º-86º F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01BC07 Azacitidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 March 2017
- Identifiers
- RxCUI 485246DailyMed set ID 3b594aba-e798-4105-b801-0b0d970747c1NDC 63323-771Application ANDA207518
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, single-dose in 1 carton / 30 mL in 1 vial, single-dose | 63323-771-39 | Fresenius Kabi | 16 March 2017 |
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 Azacitidine
Clinical summary
Azacitidine is a nucleoside metabolic inhibitor indicated for the treatment of adult patients with FAB myelodysplastic syndrome (MDS) subtypes, among other approved uses. MedsAcross supplies Azacitidine 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 AzacitidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VIDAZA prescribing information (Celgene) · U.S. National Library of Medicine, DailyMed
- Onureg: European public assessment report (EPAR) · European Medicines Agency
- Vidaza: European public assessment report (EPAR) · European Medicines Agency
Need Azacitidine 100 mg/30 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.