Medicine
Dapagliflozin 2,3-butanediol 5 mg tablet
Dapagliflozin 2,3-butanediol 5 mg tablet is a generic prescription medicine for oral 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 at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Dapagliflozin 2,3-butanediol
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 1000 tablets
- Manufacturer
- BioconIndia
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
- 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
- 1 May 2026
- Identifiers
- RxCUI 1488569, 1488574DailyMed set ID 828f1004-3647-9a13-8008-c4b3759ecfd0NDC 70377-023Application ANDA211470
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
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 |
| 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 Dapagliflozin 2,3-butanediol
Clinical summary
Dapagliflozin 2,3-butanediol is a sodium-glucose cotransporter 2 inhibitor indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. MedsAcross supplies Dapagliflozin 2,3-butanediol 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 Dapagliflozin 2,3-butanediolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DAPAGLIFLOZIN prescribing information (Biocon) · U.S. National Library of Medicine, DailyMed
Need Dapagliflozin 2,3-butanediol 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.