Medicine
Metformin 500 mg/5 mL oral solution
Metformin 500 mg/5 mL oral solution 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Metformin
- Brand
- Sold under the generic name
- Strength
- 500 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle, 473 mL, 118 mL and 6 more
- Manufacturers
- Micro LabsIndiaCamber PharmaceuticalsIndiaBionpharmaTruPharmaSaptalis PharmaceuticalsVistaPharm
- 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
- A10BA02 Metformin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 April 2020
- Identifiers
- RxCUI 861025DailyMed set ID 3ab005d4-bc99-4fdb-e063-6394a90a5124, df61d56e-18ff-404c-b671-42b39aa23574, 73691c6c-8841-4c5d-b4a5-c3ed3b5effa1 +3NDC 69452-380, 71656-017, 52817-820 +4Application ANDA219151, ANDA211309, ANDA212677 +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 |
|---|---|---|---|
| 1 bottle in 1 carton / 473 mL in 1 bottle | 31722-042-47 | Camber PharmaceuticalsIndia | 13 March 2025 |
| 473 mL in 1 bottle | 42571-360-07 | Micro LabsIndia | 20 April 2020 |
| 118 mL in 1 bottle | 42571-360-10 | Micro LabsIndia | 20 April 2020 |
| 5 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 52817-820-50 | Trupharma | 25 January 2022 |
| 5 tray in 1 case / 10 cup, unit-dose in 1 tray / 8.5 mL in 1 cup, unit-dose | 52817-821-50 | Trupharma | 25 January 2022 |
| 118 mL in 1 bottle | 69452-380-55 | Bionpharma | 26 February 2026 |
| 473 mL in 1 bottle | 69452-380-88 | Bionpharma | 28 July 2025 |
| 118 mL in 1 bottle | 71656-017-04 | Saptalis Pharmaceuticals | 31 July 2024 |
| 1 bottle in 1 carton / 473 mL in 1 bottle | 66689-318-16 | VistaPharm | 19 December 2022 |
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 |
| US FDA | First approved 3 March 1995 | Drugs@FDA |
| 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 Metformin
Clinical summary
Metformin is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is available as tablets, extended-release tablets and oral solution. MedsAcross supplies 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 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
- Glumetza prescribing information (Santarus) · U.S. National Library of Medicine, DailyMed
Need Metformin 500 mg/5 mL oral solution 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.