Medicine
Dapagliflozin 5 mg tablet
Dapagliflozin 5 mg tablet is a generic prescription medicine for oral use, made by 16 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), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Dapagliflozin
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets, 1000 tablets and 40 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAscend LaboratoriesIndiaZydus LifesciencesIndiaMacleods PharmaceuticalsIndiaMicro LabsIndiaNovadoz PharmaceuticalsIndiaAjanta PharmaIndiaAurobindo PharmaIndiaLupinIndiaSandoz16 labelers on the register
- 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
- ATC code
- A10BK01 Dapagliflozin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 April 2026
- Identifiers
- RxCUI 1488569, 1488574DailyMed set ID 20a83ea2-6ad8-4bbb-b516-73c0a9e37399, d44f7eed-dd51-40d1-8408-8fb331e1f1f6, c4264ff6-5199-49e9-91d3-3ad67b42f88d +15NDC 71921-420, 46708-392, 50090-7971 +15Application ANDA211156, ANDA211560, ANDA211468 +10
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
A sample of 40 packs from 16 labelers. The register lists 43 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 46708-392-30 | Alembic PharmaceuticalsIndia | 6 April 2026 |
| 90 tablet, film coated in 1 bottle | 46708-392-90 | Alembic PharmaceuticalsIndia | 20 April 2026 |
| 1000 tablet, film coated in 1 bottle | 46708-392-91 | Alembic PharmaceuticalsIndia | 6 April 2026 |
| 30 tablet, film coated in 1 bottle | 62332-392-30 | Alembic PharmaceuticalsIndia | 6 April 2026 |
| 90 tablet, film coated in 1 bottle | 62332-392-90 | Alembic PharmaceuticalsIndia | 20 April 2026 |
| 1000 tablet, film coated in 1 bottle | 62332-392-91 | Alembic PharmaceuticalsIndia | 6 April 2026 |
| 30 tablet in 1 bottle | 70710-1380-3 | Zydus LifesciencesIndia | 6 April 2026 |
| 90 tablet in 1 bottle | 70710-1380-9 | Zydus LifesciencesIndia | 6 April 2026 |
| 30 tablet in 1 bottle | 70771-1714-3 | Zydus LifesciencesIndia | 6 April 2026 |
| 90 tablet in 1 bottle | 70771-1714-9 | Zydus LifesciencesIndia | 6 April 2026 |
| 30 tablet in 1 bottle | 27241-151-01 | Ajanta PharmaIndia | 6 April 2026 |
| 90 tablet in 1 bottle | 27241-151-90 | Ajanta PharmaIndia | 2 September 2026 |
| 500 tablet, film coated in 1 bottle | 67877-608-05 | Ascend LaboratoriesIndia | 6 April 2026 |
| 30 tablet, film coated in 1 bottle | 67877-608-30 | Ascend LaboratoriesIndia | 6 April 2026 |
| 1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 67877-608-33 | Ascend LaboratoriesIndia | 6 April 2026 |
| 90 tablet, film coated in 1 bottle | 67877-608-90 | Ascend LaboratoriesIndia | 6 April 2026 |
| 30 tablet, film coated in 1 bottle | 59651-159-30 | Aurobindo PharmaIndia | 6 April 2026 |
| 90 tablet, film coated in 1 bottle | 59651-159-90 | Aurobindo PharmaIndia | 8 May 2026 |
| 30 tablet in 1 bottle | 70748-105-06 | LupinIndia | 8 April 2026 |
| 30 tablet in 1 bottle | 33342-585-07 | Macleods PharmaceuticalsIndia | 6 April 2026 |
| 90 tablet in 1 bottle | 33342-585-10 | Macleods PharmaceuticalsIndia | 6 April 2026 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 33342-585-12 | Macleods PharmaceuticalsIndia | 6 April 2026 |
| 1000 tablet in 1 bottle | 42571-317-10 | Micro LabsIndia | 1 October 2026 |
| 30 tablet in 1 bottle | 42571-317-30 | Micro LabsIndia | 1 October 2026 |
| 90 tablet in 1 bottle | 42571-317-90 | Micro LabsIndia | 1 October 2026 |
| 30 tablet, film coated in 1 bottle | 72205-432-01 | Novadoz PharmaceuticalsIndia | 7 April 2026 |
| 500 tablet, film coated in 1 bottle | 72205-432-02 | Novadoz PharmaceuticalsIndia | 7 April 2026 |
| 90 tablet, film coated in 1 bottle | 72205-432-03 | Novadoz PharmaceuticalsIndia | 7 April 2026 |
| 30 tablet, film coated in 1 bottle | 70954-856-10 | ANI Pharmaceuticals | 13 May 2026 |
| 30 tablet, film coated in 1 bottle, plastic | 60505-4911-3 | Apotex | 8 April 2026 |
| 90 tablet in 1 bottle | 71921-420-09 | Florida Pharmaceutical Products | 6 April 2026 |
| 30 tablet in 1 bottle | 71921-420-33 | Florida Pharmaceutical Products | 6 April 2026 |
| 500 tablet in 1 bottle | 71921-420-50 | Florida Pharmaceutical Products | 6 April 2026 |
| 100 tablet, film coated in 1 bottle, plastic | 0781-5985-01 | Sandoz | 6 April 2026 |
| 500 tablet, film coated in 1 bottle, plastic | 0781-5985-05 | Sandoz | 6 April 2026 |
| 1000 tablet, film coated in 1 bottle, plastic | 0781-5985-10 | Sandoz | 6 April 2026 |
| 30 tablet, film coated in 1 bottle, plastic | 0781-5985-31 | Sandoz | 6 April 2026 |
| 500 tablet, film coated in 1 bottle | 0480-3527-05 | Teva Pharmaceuticals | 4 June 2026 |
| 30 tablet, film coated in 1 bottle | 0480-3527-56 | Teva Pharmaceuticals | 8 April 2026 |
| 90 tablet, film coated in 1 bottle | 0480-3527-98 | Teva Pharmaceuticals | 27 April 2026 |
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 Dapagliflozin
Clinical summary
Dapagliflozin 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 cardiovascular (CV) disease or multiple CV risk factors. MedsAcross supplies Dapagliflozin 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 DapagliflozinFor 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 (Micro Labs) · U.S. National Library of Medicine, DailyMed
- Edistride: European public assessment report (EPAR) · European Medicines Agency
- Forxiga: European public assessment report (EPAR) · European Medicines Agency
Need Dapagliflozin 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.