Medicine
Gentamicin 60 mg/50 mL injection
Gentamicin 60 mg/50 mL injection is a generic prescription medicine for intravenous use, 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
It is recommended the product be stored at room temperature (25°C), brief…
Key facts
- Active ingredient (INN)
- Gentamicin
- Brand
- Sold under the generic name
- Strength
- 60 mg/50 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 50 mL
- Manufacturer
- Baxter Healthcare
- Origin register
- US FDA, United States
- Storage
- It is recommended the product be stored at room temperature (25°C), brief exposure up to 40°C does not adversely affect the product.
- 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
- 7 September 1982
- Identifiers
- RxCUI 197736, 242816, 310473 +3DailyMed set ID 449c9a41-d61e-49fd-b5e3-d76f74b92acfNDC 0338-0507Application ANDA062373
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 50 mL in 1 bag | 0338-0507-41 | Baxter Healthcare | 7 September 1982 |
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 60 mg/50 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.