Medicine
Metronidazole 500 mg/100 mL injection
Metronidazole 500 mg/100 mL injection is a generic prescription medicine for intravenous 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
Protect from freezing. Store at 20° to 25°C (68° to 77°F). It is recommended…
Key facts
- Active ingredient (INN)
- Metronidazole
- Brand
- Sold under the generic name
- Strength
- 500 mg/100 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 4 pouches of 100 mL, 1 bag of 100 mL, 24 bags of 100 mL and 7 more
- Manufacturers
- Gland PharmaIndiaSun Pharmaceutical IndustriesIndiaBaxter HealthcareAmneal PharmaceuticalsCivicaHenry ScheinHospiraSagent PharmaceuticalsWG Critical Care
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at 20° to 25°C (68° to 77°F). It is recommended that the product be stored at room temperature (25°C), however, brief exposure up to 40°C does not adversely affect the product. Protect from light until use.
- 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
- 24 December 1981
- Identifiers
- RxCUI 311683DailyMed set ID d46870f5-e2b1-46bd-8413-4a0a8bcf3175, 9d762edb-12ac-429d-b1f0-7af5d3b909d4, 7187779a-1f4c-4607-af53-4119e324aad5 +7NDC 25021-131, 0338-9541, 47335-993 +7Application ANDA206191, NDA018657, ANDA212435 +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 |
|---|---|---|---|
| 4 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 68083-373-04 | Gland PharmaIndia | 3 August 2020 |
| 1 bag in 1 pouch / 100 mL in 1 bag | 47335-993-01 | Sun Pharmaceutical IndustriesIndia | 10 August 2021 |
| 24 bag in 1 carton / 100 mL in 1 bag | 0338-1055-48 | Baxter Healthcare | 24 December 1981 |
| 24 bag in 1 carton / 100 mL in 1 bag | 0338-9541-24 | Baxter Healthcare | 24 December 1981 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 80830-2465-9 | Amneal Pharmaceuticals | 17 June 2023 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 0409-0152-24 | Hospira | 13 December 2021 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 25021-131-82 | Sagent Pharmaceuticals | 15 November 2009 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 44567-750-24 | WG Critical Care | 31 January 2025 |
| 24 bag in 1 carton / 100 mL in 1 bag | 72572-540-24 | Civica | 13 November 2025 |
| 1 bag in 1 bag / 100 mL in 1 bag | 0404-9991-00 | Henry Schein | 24 February 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 500 mg/100 mL injection 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.