Medicine
Saxagliptin 5 mg tablet
Saxagliptin 5 mg tablet is a generic prescription medicine for oral use, made by 3 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 to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Saxagliptin
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 7 more
- Manufacturers
- Aurobindo PharmaIndiaGlenmark PharmaceuticalsIndiaMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 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
- A10BH03 Saxagliptin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 July 2023
- Identifiers
- RxCUI 858036, 858042DailyMed set ID e286ffd4-c598-47fb-af06-2e15f7e6f99f, 6e8d8c4f-96eb-4b64-9c8c-4a5448a23a78, f3ea58bb-0002-4a5d-9213-7e9066e3dc9cNDC 68462-727, 0378-4706, 65862-826Application ANDA205994, ANDA205980, ANDA205972
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 |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 65862-826-01 | Aurobindo PharmaIndia | 31 July 2023 |
| 500 tablet, film coated in 1 bottle | 65862-826-05 | Aurobindo PharmaIndia | 31 July 2023 |
| 30 tablet, film coated in 1 bottle | 65862-826-30 | Aurobindo PharmaIndia | 31 July 2023 |
| 90 tablet, film coated in 1 bottle | 65862-826-90 | Aurobindo PharmaIndia | 31 July 2023 |
| 500 tablet, film coated in 1 bottle | 68462-727-05 | Glenmark PharmaceuticalsIndia | 31 July 2023 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 68462-727-14 | Glenmark PharmaceuticalsIndia | 31 July 2023 |
| 30 tablet, film coated in 1 bottle | 68462-727-30 | Glenmark PharmaceuticalsIndia | 31 July 2023 |
| 90 tablet, film coated in 1 bottle | 68462-727-90 | Glenmark PharmaceuticalsIndia | 31 July 2023 |
| 90 tablet, film coated in 1 bottle, plastic | 0378-4706-77 | Mylan Pharmaceuticals | 4 August 2023 |
| 30 tablet, film coated in 1 bottle, plastic | 0378-4706-93 | Mylan Pharmaceuticals | 4 August 2023 |
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 Saxagliptin
Clinical summary
Saxagliptin is a dipeptidyl peptidase 4 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, among other approved uses. MedsAcross supplies Saxagliptin 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 SaxagliptinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Saxagliptin prescribing information (Aurobindo Pharma) · U.S. National Library of Medicine, DailyMed
- Onglyza: European public assessment report (EPAR) · European Medicines Agency
Need Saxagliptin 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.