Medicine
Janumet XR 500 mg/50 mg extended-release tablet
Janumet XR 500 mg/50 mg extended-release tablet is a prescription medicine containing Metformin and Sitagliptin for oral use, marketed by Merck Sharp & Dohme, 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 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). Store…
Key facts
- Active ingredient (INN)
- Metformin and Sitagliptin
- Brand
- Janumet XR
- Strength
- 500 mg/50 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 60 tablets, 180 tablets, 1000 tablets
- Marketing authorisation holder
- Merck Sharp & Dohme
- Manufacturer
- Merck Sharp & Dohme
- Origin register
- US FDA, United States
- Storage
- Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). Store in a dry place with cap tightly closed.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A10BD07 Metformin and Sitagliptin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 February 2012
- Identifiers
- RxCUI 1243833, 1243843, 1243848 +3DailyMed set ID 64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50NDC 0006-0078Application NDA202270
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 tablet, film coated, extended release in 1 bottle | 0006-0078-61 | Merck Sharp & Dohme | 2 February 2012 |
| 180 tablet, film coated, extended release in 1 bottle | 0006-0078-62 | Merck Sharp & Dohme | 2 February 2012 |
| 1000 tablet, film coated, extended release in 1 bottle | 0006-0078-82 | Merck Sharp & Dohme | 2 February 2012 |
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 Metformin and Sitagliptin 500 mg/50 mg extended-release tablet.
Other strengths and forms of Metformin and Sitagliptin
Clinical summary
Metformin and Sitagliptin is a fixed-dose combination of a biguanide and a dipeptidyl peptidase 4 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MedsAcross supplies Metformin and 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 Metformin and 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
- JANUMET prescribing information (Merck Sharp & Dohme) · U.S. National Library of Medicine, DailyMed
- Efficib: European public assessment report (EPAR) · European Medicines Agency
- Janumet: European public assessment report (EPAR) · European Medicines Agency
Need Janumet XR 500 mg/50 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.