Medicine
Xigduo XR 5 mg/500 mg extended-release tablet
Xigduo XR 5 mg/500 mg extended-release tablet is a prescription medicine containing Dapagliflozin propanediol and Metformin for oral use, marketed by AstraZeneca Pharmaceuticals, 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 propanediol and Metformin
- Brand
- Xigduo XR
- Strength
- 5 mg/500 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets
- Marketing authorisation holder
- AstraZeneca Pharmaceuticals
- Manufacturer
- AstraZeneca Pharmaceuticals
- 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
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 October 2014
- Identifiers
- RxCUI 1593058, 1593068, 1593070 +7DailyMed set ID ac8a0f7b-9f69-4495-abbc-3a47cd75a859NDC 0310-6250Application NDA205649
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 |
|---|---|---|---|
| 30 tablet, film coated, extended release in 1 bottle, plastic | 0310-6250-30 | AstraZeneca Pharmaceuticals | 1 December 2014 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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 propanediol and Metformin
Clinical summary
Dapagliflozin propanediol and Metformin is a fixed-dose combination of a biguanide and a sodium-glucose cotransporter 2 inhibitor. It is available as extended-release tablets for oral use. MedsAcross supplies Dapagliflozin propanediol 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 propanediol 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
- XIGDUO XR prescribing information (AstraZeneca Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Xigduo XR 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.