Medicine
Gentamicin 0.1% ointment
Gentamicin 0.1% ointment is a generic prescription medicine for topical use, made by 4 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 20-25°C (68-77°F).
Key facts
- Active ingredient (INN)
- Gentamicin
- Brand
- Sold under the generic name
- Strength
- 0.1%
- Dosage form
- Ointment
- Route
- Topical
- Packs
- 1 tube and 4 more
- Manufacturers
- Cosette PharmaceuticalsEncube EthicalsPadagis Israel PharmaceuticalsProficient Rx
- Origin register
- US FDA, United States
- Storage
- Store at 20-25°C (68-77°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 July 2006
- Identifiers
- RxCUI 310465DailyMed set ID 16474069-510b-0754-9d78-9bc0354f6549, cf4386ba-c62a-4ee8-ab59-1bb2e737a5da, a9486ae1-350b-41c5-ae0c-a4d692bb2dfd +1NDC 0713-0682, 71205-560, 45802-046 +1Application ANDA064054, ANDA062351, ANDA209233
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 / 15 g in 1 tube | 0713-0682-15 | Cosette Pharmaceuticals | 21 December 2017 |
| 1 tube in 1 carton / 30 g in 1 tube | 0713-0682-31 | Cosette Pharmaceuticals | 21 December 2017 |
| 1 tube in 1 carton / 15 g in 1 tube | 21922-110-04 | Encube Ethicals | 1 October 2026 |
| 1 tube in 1 carton / 30 g in 1 tube | 21922-110-05 | Encube Ethicals | 1 October 2026 |
| 1 tube in 1 carton / 30 g in 1 tube | 45802-046-11 | Padagis Israel Pharmaceuticals | 28 August 2006 |
| 1 tube in 1 carton / 15 g in 1 tube | 45802-046-35 | Padagis Israel Pharmaceuticals | 10 July 2006 |
| 1 tube in 1 carton / 15 g in 1 tube | 71205-560-15 | Proficient Rx | 6 May 2021 |
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 0.1% ointment 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.