Medicine
Metronidazole 0.75% cream
Metronidazole 0.75% cream is a generic prescription medicine for topical use, made by 9 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 (68ºF to 77°F), excursions permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Metronidazole
- Brand
- Sold under the generic name
- Strength
- 0.75%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube, 45 g and 6 more
- Manufacturers
- Aurobindo PharmaIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaBryant Ranch PrepackCosette PharmaceuticalsFougera PharmaceuticalsMayne PharmaPrasco LaboratoriesPreferred Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68ºF to 77°F), excursions permitted between 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
- 28 May 2004
- Identifiers
- RxCUI 311678DailyMed set ID 93299502-6cb0-48a4-8190-50fef74bdbee, 567c7c0c-ffc1-47c1-b0fb-8715bf3d76b9, 0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74 +6NDC 72578-129, 68308-711, 59651-770 +6Application ANDA217128, NDA020531, ANDA219295 +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 | 59651-770-46 | Aurobindo PharmaIndia | 9 July 2025 |
| 1 tube in 1 carton / 45 g in 1 tube | 72578-129-08 | Viona PharmaceuticalsIndia | 31 May 2023 |
| 1 tube in 1 carton / 45 g in 1 tube | 70771-1834-4 | Zydus LifesciencesIndia | 31 May 2023 |
| 1 tube in 1 carton / 45 g in 1 tube | 0713-0633-37 | Cosette Pharmaceuticals | 13 March 2008 |
| 45 g in 1 tube | 0168-0323-46 | Fougera Pharmaceuticals | 28 May 2004 |
| 1 tube in 1 carton / 45 g in 1 tube | 68308-711-45 | Mayne Pharma | 19 May 2025 |
| 45 g in 1 tube | 72162-2259-2 | Bryant Ranch Prepack | 23 February 2024 |
| 1 tube in 1 carton / 45 g in 1 tube | 66993-960-45 | Prasco Laboratories | 18 June 2009 |
| 1 tube in 1 carton / 45 g in 1 tube | 68788-8552-4 | Preferred Pharmaceuticals | 20 November 2023 |
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 0.75% cream 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.