Medicine
Metronidazole 500 mg tablet
Metronidazole 500 mg tablet is a generic prescription medicine for oral use, made by 35 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° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Metronidazole
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 236 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaUnichem LaboratoriesIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaAvet PharmaceuticalsIndiaCadila PharmaceuticalsIndiaPharmPakAmici PharmaKanchan Healthcare35 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). 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
- 16 July 1986
- Identifiers
- RxCUI 311681, 314106, 2702348DailyMed set ID 356579f3-a9ed-49cf-bc0d-47b58a58cf85, 4748ba37-9d66-497d-aa9f-ca2d541c5f41, dc8e448e-ac4e-4efc-8851-c368e31b9d69 +37NDC 71335-2681, 72162-2678, 85766-024 +37Application ANDA206560, ANDA209794, ANDA203458 +6
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
A sample of 40 packs from 35 labelers. The register lists 239 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 15955-389-01 | Alembic PharmaceuticalsIndia | 26 June 2019 |
| 500 tablet in 1 bottle | 15955-389-05 | Alembic PharmaceuticalsIndia | 26 June 2019 |
| 30 tablet in 1 bottle | 46708-429-30 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 100 tablet in 1 bottle | 46708-429-31 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 50 tablet in 1 bottle | 46708-429-50 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 500 tablet in 1 bottle | 46708-429-71 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 1000 tablet in 1 bottle | 46708-429-91 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 30 tablet in 1 bottle | 62332-017-30 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 100 tablet in 1 bottle | 62332-017-31 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 50 tablet in 1 bottle | 62332-017-50 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 500 tablet in 1 bottle | 62332-017-71 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 1000 tablet in 1 bottle | 62332-017-91 | Alembic PharmaceuticalsIndia | 1 December 2016 |
| 100 tablet in 1 bottle | 65862-695-01 | Aurobindo PharmaIndia | 29 May 2015 |
| 500 tablet in 1 bottle | 65862-695-05 | Aurobindo PharmaIndia | 29 May 2015 |
| 50 tablet in 1 bottle | 65862-695-50 | Aurobindo PharmaIndia | 29 May 2015 |
| 1000 tablet in 1 bottle | 65862-695-99 | Aurobindo PharmaIndia | 29 May 2015 |
| 100 tablet in 1 bottle, plastic | 23155-652-01 | Avet PharmaceuticalsIndia | 29 November 2017 |
| 500 tablet in 1 bottle, plastic | 23155-652-05 | Avet PharmaceuticalsIndia | 29 November 2017 |
| 50 tablet, film coated in 1 bottle | 71209-063-02 | Cadila PharmaceuticalsIndia | 29 December 2017 |
| 500 tablet, film coated in 1 bottle | 71209-063-10 | Cadila PharmaceuticalsIndia | 29 December 2017 |
| 100 tablet, film coated in 1 bottle, plastic | 29300-227-01 | Unichem LaboratoriesIndia | 1 June 2014 |
| 500 tablet, film coated in 1 bottle, plastic | 29300-227-05 | Unichem LaboratoriesIndia | 1 June 2014 |
| 1000 tablet, film coated in 1 bottle, plastic | 29300-227-10 | Unichem LaboratoriesIndia | 1 June 2014 |
| 50 tablet, film coated in 1 bottle, plastic | 29300-227-46 | Unichem LaboratoriesIndia | 1 June 2014 |
| 100 tablet in 1 bottle | 72578-008-01 | Viona PharmaceuticalsIndia | 23 February 2019 |
| 500 tablet in 1 bottle | 72578-008-05 | Viona PharmaceuticalsIndia | 23 February 2019 |
| 50 tablet in 1 bottle | 72578-008-18 | Viona PharmaceuticalsIndia | 23 February 2019 |
| 100 tablet in 1 bottle | 70771-1046-1 | Zydus LifesciencesIndia | 23 February 2019 |
| 500 tablet in 1 bottle | 70771-1046-5 | Zydus LifesciencesIndia | 23 February 2019 |
| 50 tablet in 1 bottle | 70771-1046-7 | Zydus LifesciencesIndia | 23 February 2019 |
| 100 tablet in 1 bottle | 69292-208-01 | Amici Pharma | 22 November 2019 |
| 500 tablet in 1 bottle | 69292-208-50 | Amici Pharma | 22 November 2019 |
| 90 tablet in 1 bottle | 62135-796-90 | Chartwell RX | 7 November 2023 |
| 50 tablet, film coated in 1 bottle | 85742-025-24 | Kanchan Healthcare | 19 June 2026 |
| 500 tablet, film coated in 1 bottle | 85742-025-25 | Kanchan Healthcare | 19 June 2026 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 58657-934-01 | Method Pharmaceuticals | 1 July 2025 |
| 50 blister pack in 1 carton / 1 tablet in 1 blister pack | 58657-934-05 | Method Pharmaceuticals | 1 July 2025 |
| 1 bottle in 1 box / 1 tablet, film coated in 1 bottle | 54348-740-00 | PharmPak | 10 July 2019 |
| 1 bottle in 1 box / 4 tablet, film coated in 1 bottle | 54348-740-04 | PharmPak | 10 July 2019 |
| 1 bottle in 1 box / 9 tablet, film coated in 1 bottle | 54348-740-09 | PharmPak | 10 July 2019 |
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 500 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.