Medicine
Gentamicin 800 mg/20 mL injection
Gentamicin 800 mg/20 mL injection is a generic prescription medicine for intramuscular, intravenous 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° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Gentamicin
- Brand
- Sold under the generic name
- Strength
- 800 mg/20 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 25 vials of 20 mL, 10 vials of 20 mL, 25 pouches of 20 mL and 4 more
- Manufacturers
- EugiaIndiaFresenius KabiHealthFirstHenry ScheinHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D06AX07 Gentamicin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 August 2000
- Identifiers
- RxCUI 313996DailyMed set ID c1ff0cdc-ac5d-30ca-e053-2a95a90a5066, 60ca1487-392d-4721-aa45-3de38722896c, 84f5c763-1cd3-4d85-9afb-934db8666fbf +4NDC 51662-1508, 55150-403, 63323-010 +2Application ANDA062366, ANDA215237, ANDA062251
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 |
|---|---|---|---|
| 25 vial, multi-dose in 1 carton / 20 mL in 1 vial, multi-dose | 55150-403-25 | EugiaIndia | 8 January 2024 |
| 25 vial in 1 tray / 20 mL in 1 vial | 63323-010-20 | Fresenius Kabi | 10 August 2000 |
| 25 vial, multi-dose in 1 tray / 20 mL in 1 vial, multi-dose | 63323-010-95 | Fresenius Kabi | 10 August 2000 |
| 25 vial, multi-dose in 1 tray / 20 mL in 1 vial, multi-dose | 63323-010-96 | Fresenius Kabi | 10 August 2000 |
| 10 vial in 1 carton / 20 mL in 1 vial | 0143-9129-10 | Hikma Pharmaceuticals | 15 February 2022 |
| 25 pouch in 1 box / 1 vial in 1 pouch / 20 mL in 1 vial | 51662-1508-3 | HealthFirst | 10 May 2021 |
| 1 vial, multi-dose in 1 bag / 20 mL in 1 vial, multi-dose | 0404-9866-20 | Henry Schein | 10 January 2022 |
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 19 June 1970 | 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 Gentamicin
Clinical summary
Gentamicin is an aminoglycoside antibacterial. It is available as injection, eye drops and ointment for intravenous, intramuscular and ophthalmic use. MedsAcross supplies Gentamicin 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 GentamicinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- GENTAMICIN SULFATE prescribing information (Encube Ethicals) · U.S. National Library of Medicine, DailyMed
Need Gentamicin 800 mg/20 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.