Medicine
Sitagliptin 100 mg tablet
Sitagliptin 100 mg tablet is a generic prescription medicine for oral use, made by 5 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 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC…
Key facts
- Active ingredient (INN)
- Sitagliptin
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets, 1000 tablets and 11 more
- Manufacturers
- Zydus LifesciencesIndiaSandozTeva PharmaceuticalsApotexGolden State Medical Supply
- Origin register
- US FDA, United States
- Storage
- Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (69ºF to 86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A10BH01 Sitagliptin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 November 2023
- Identifiers
- RxCUI 2709603, 2709608, 2709612 +3DailyMed set ID cebc8388-c9db-4e27-8d6b-0d9bdc9d766d, 58e23b30-451c-f451-e063-6394a90a35a7, e5ac97e8-3a0b-4750-8e3f-337412570746 +3NDC 0781-5770, 84677-051, 70771-1792 +3Application ANDA202387, ANDA202425, NDA211566 +1
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 |
|---|---|---|---|
| 30 tablet in 1 bottle | 70710-1901-3 | Zydus LifesciencesIndia | 30 November 2023 |
| 90 tablet in 1 bottle | 70710-1901-9 | Zydus LifesciencesIndia | 30 November 2023 |
| 30 tablet in 1 bottle | 70771-1792-3 | Zydus LifesciencesIndia | 30 November 2023 |
| 90 tablet in 1 bottle | 70771-1792-9 | Zydus LifesciencesIndia | 30 November 2023 |
| 30 tablet, film coated in 1 bottle, plastic | 60505-3645-3 | Apotex | 28 May 2026 |
| 90 tablet, film coated in 1 bottle, plastic | 60505-3645-9 | Apotex | 28 May 2026 |
| 1000 tablet, film coated in 1 bottle | 0781-5770-10 | Sandoz | 14 January 2026 |
| 30 tablet, film coated in 1 bottle | 0781-5770-31 | Sandoz | 14 January 2026 |
| 90 tablet, film coated in 1 bottle | 0781-5770-92 | Sandoz | 14 January 2026 |
| 1000 tablet, film coated in 1 bottle | 0480-2609-10 | Teva Pharmaceuticals | 28 May 2026 |
| 30 tablet, film coated in 1 bottle | 0480-2609-56 | Teva Pharmaceuticals | 28 May 2026 |
| 90 tablet, film coated in 1 bottle | 0480-2609-98 | Teva Pharmaceuticals | 28 May 2026 |
| 30 tablet, film coated in 1 bottle, plastic | 84677-051-30 | Golden State Medical Supply | 1 June 2026 |
| 90 tablet, film coated in 1 bottle, plastic | 84677-051-90 | Golden State Medical Supply | 1 June 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
Alternatives
Other makers and brands of Sitagliptin 100 mg tablet.
Other strengths and forms of Sitagliptin
Clinical summary
Sitagliptin 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. It is available as tablets and oral solution. MedsAcross supplies Sitagliptin 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 SitagliptinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- JANUVIA prescribing information (Merck Sharp & Dohme) · U.S. National Library of Medicine, DailyMed
- Januvia: European public assessment report (EPAR) · European Medicines Agency
- Ristaben: European public assessment report (EPAR) · European Medicines Agency
Need Sitagliptin 100 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.