Medicine
Metronidazole 125 mg tablet
Metronidazole 125 mg tablet is a generic prescription medicine for oral use, made by 2 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 20º to 25ºC (68º to 77ºF). Protect from light
Key facts
- Active ingredient (INN)
- Metronidazole
- Brand
- Sold under the generic name
- Strength
- 125 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 56 tablets, 100 blister pack and 5 more
- Manufacturers
- Method PharmaceuticalsBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF). Protect from light
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A01AB17 Metronidazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 January 2025
- Identifiers
- RxCUI 311681, 314106, 2702348DailyMed set ID 2ae49bf4-a23b-bdcc-e063-6294a90a80a9, 99886f54-4ebe-4a2d-b779-bcfbb0634db1, ac7e80ce-6174-4246-a955-a92adc516571NDC 58657-739, 58657-939, 72162-2468 +1Application ANDA070772
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 in 1 bottle | 58657-739-01 | Method Pharmaceuticals | 4 January 2025 |
| 56 tablet in 1 bottle | 58657-739-56 | Method Pharmaceuticals | 4 January 2025 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 58657-939-01 | Method Pharmaceuticals | 1 July 2025 |
| 30 blister pack in 1 carton / 1 tablet in 1 blister pack | 58657-939-03 | Method Pharmaceuticals | 4 May 2026 |
| 50 blister pack in 1 carton / 1 tablet in 1 blister pack | 58657-939-05 | Method Pharmaceuticals | 1 July 2025 |
| 56 tablet in 1 bottle | 71335-2949-1 | Bryant Ranch Prepack | 30 October 2025 |
| 56 tablet in 1 bottle | 72162-2468-2 | Bryant Ranch Prepack | 27 March 2025 |
| 500 tablet in 1 bottle | 72162-2468-5 | Bryant Ranch Prepack | 28 April 2025 |
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 18 July 1963 | 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 Metronidazole
Clinical summary
Metronidazole is a nitroimidazole antimicrobial indicated in the treatment of serious infections caused by susceptible anaerobic bacteria, among other approved uses. It is available as tablets, vaginal gel and gel for oral and topical use. MedsAcross supplies Metronidazole 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 MetronidazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Metronidazole prescribing information (Civica) · U.S. National Library of Medicine, DailyMed
Need Metronidazole 125 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.