Medicine
Dapagliflozin and Metformin 5 mg/500 mg extended-release tablet
Dapagliflozin and Metformin 5 mg/500 mg extended-release tablet is a generic prescription medicine for oral use, made by 6 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° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Dapagliflozin and Metformin
- Brand
- Sold under the generic name
- Strength
- 5 mg/500 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 500 tablets, 30 tablets, 3 blister pack and 12 more
- Manufacturers
- Macleods PharmaceuticalsIndiaMicro LabsIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaNovadoz PharmaceuticalsIndiaLupinIndia
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A10BD15 Dapagliflozin and Metformin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 April 2026
- Identifiers
- RxCUI 1593058, 1593068, 1593070 +1DailyMed set ID 513bdf9f-774c-4f7f-935a-54d3885e80a4, e6957674-86c1-4536-8e23-54ad7f2cacc4, 4f890458-be94-4baf-b606-83a097e1e23e +3NDC 59651-154, 70748-101, 72205-434 +3Application ANDA211489, ANDA211579, ANDA211479 +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 |
|---|---|---|---|
| 500 tablet, film coated, extended release in 1 bottle | 67877-619-05 | Ascend LaboratoriesIndia | 6 April 2026 |
| 30 tablet, film coated, extended release in 1 bottle | 67877-619-30 | Ascend LaboratoriesIndia | 6 April 2026 |
| 500 tablet, film coated, extended release in 1 bottle | 59651-154-05 | Aurobindo PharmaIndia | 6 April 2026 |
| 30 tablet, film coated, extended release in 1 bottle | 59651-154-30 | Aurobindo PharmaIndia | 6 April 2026 |
| 30 tablet, extended release in 1 bottle | 70748-101-06 | LupinIndia | 17 April 2026 |
| 3 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 33342-406-06 | Macleods PharmaceuticalsIndia | 6 April 2026 |
| 30 tablet, extended release in 1 bottle | 33342-406-07 | Macleods PharmaceuticalsIndia | 6 April 2026 |
| 60 tablet, extended release in 1 bottle | 33342-406-09 | Macleods PharmaceuticalsIndia | 6 April 2026 |
| 90 tablet, extended release in 1 bottle | 33342-406-10 | Macleods PharmaceuticalsIndia | 6 April 2026 |
| 500 tablet, extended release in 1 bottle | 33342-406-15 | Macleods PharmaceuticalsIndia | 6 April 2026 |
| 500 tablet, film coated, extended release in 1 bottle | 42571-320-05 | Micro LabsIndia | 1 October 2026 |
| 30 tablet, film coated, extended release in 1 bottle | 42571-320-30 | Micro LabsIndia | 1 October 2026 |
| 90 tablet, film coated, extended release in 1 bottle | 42571-320-90 | Micro LabsIndia | 1 October 2026 |
| 30 tablet, film coated, extended release in 1 bottle | 72205-434-01 | Novadoz PharmaceuticalsIndia | 9 April 2026 |
| 500 tablet, film coated, extended release in 1 bottle | 72205-434-02 | Novadoz PharmaceuticalsIndia | 9 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 and Metformin
Clinical summary
Dapagliflozin and Metformin is a fixed-dose combination of a biguanide and a sodium-glucose cotransporter 2 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MedsAcross supplies Dapagliflozin and Metformin 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 and MetforminFor 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 and Metformin Hydrochloride prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
- Ebymect: European public assessment report (EPAR) · European Medicines Agency
- Xigduo: European public assessment report (EPAR) · European Medicines Agency
Need Dapagliflozin and Metformin 5 mg/500 mg extended-release 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.