Medicine
Metronidazole 1% gel
Metronidazole 1% gel is a generic prescription medicine for topical use, made by 5 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 from 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Metronidazole
- Brand
- Sold under the generic name
- Strength
- 1%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 tube, 1 bottle and 13 more
- Manufacturers
- Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaAurobindo PharmaIndiaMayne PharmaCosette Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted from 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
- A01AB17 Metronidazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 March 2017
- Identifiers
- RxCUI 577237DailyMed set ID a0d7d4e8-28c0-4211-8d76-73a173b48d9a, 5a504f74-bccd-433a-bd5b-6822f98c34df, 9f56cc00-6383-48c8-95ee-e6a404a0237b +4NDC 0713-0574, 51672-4164, 62332-630 +4Application ANDA216692, ANDA204651, ANDA212646 +2
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 tube in 1 carton / 45 g in 1 tube | 46708-630-45 | Alembic PharmaceuticalsIndia | 17 March 2025 |
| 1 bottle, pump in 1 carton / 55 g in 1 bottle, pump | 46708-630-55 | Alembic PharmaceuticalsIndia | 17 March 2025 |
| 1 tube in 1 carton / 60 g in 1 tube | 46708-630-60 | Alembic PharmaceuticalsIndia | 17 March 2025 |
| 1 tube in 1 carton / 45 g in 1 tube | 62332-630-45 | Alembic PharmaceuticalsIndia | 6 September 2021 |
| 1 bottle, pump in 1 carton / 55 g in 1 bottle, pump | 62332-630-55 | Alembic PharmaceuticalsIndia | 6 September 2021 |
| 1 tube in 1 carton / 60 g in 1 tube | 62332-630-60 | Alembic PharmaceuticalsIndia | 6 September 2021 |
| 1 tube in 1 carton / 60 g in 1 tube | 51672-4164-3 | Sun Pharmaceutical IndustriesIndia | 14 March 2017 |
| 1 tube in 1 carton / 45 g in 1 tube | 51672-4164-6 | Sun Pharmaceutical IndustriesIndia | 14 March 2017 |
| 1 bottle, pump in 1 carton / 55 g in 1 bottle, pump | 51672-4164-9 | Sun Pharmaceutical IndustriesIndia | 15 August 2017 |
| 1 tube in 1 carton / 60 g in 1 tube | 51672-4215-3 | Sun Pharmaceutical IndustriesIndia | 9 April 2019 |
| 1 tube in 1 carton / 45 g in 1 tube | 51672-4215-6 | Sun Pharmaceutical IndustriesIndia | 9 April 2019 |
| 1 bottle, pump in 1 carton / 55 g in 1 bottle, pump | 51672-4215-9 | Sun Pharmaceutical IndustriesIndia | 9 April 2019 |
| 1 tube in 1 carton / 60 g in 1 tube | 59651-813-60 | Aurobindo PharmaIndia | 15 October 2024 |
| 1 tube in 1 carton / 60 g in 1 tube | 0713-0574-60 | Cosette Pharmaceuticals | 1 February 2023 |
| 1 bottle, pump in 1 carton / 55 g in 1 bottle, pump | 68308-663-55 | Mayne Pharma | 10 November 2023 |
| 1 tube in 1 carton / 60 g in 1 tube | 68308-663-60 | Mayne Pharma | 19 May 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 1% gel 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.