Medicine
Gentamicin 3 mg/mL eye drops
Gentamicin 3 mg/mL eye drops is a generic prescription medicine for ophthalmic use, made by 7 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 between 2°C to 25°C (36°F to 77°F).
Key facts
- Active ingredient (INN)
- Gentamicin
- Brand
- Sold under the generic name
- Strength
- 3 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle, 5 mL and 8 more
- Manufacturers
- NuCare Pharmaceuticals,IncDirect_RxProficient RxA-S Medication SolutionsAsclemedBausch & LombPreferred Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store between 2°C to 25°C (36°F 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
- 11 May 1994
- Identifiers
- RxCUI 310467DailyMed set ID 76fabcd6-4da3-49e3-85a1-ca4fac55a207, 0bef2a01-69d0-cf50-e063-6294a90a4c52, b59e49e0-640b-43c3-ad07-711d1bb154e9 +8NDC 50090-0569, 68071-3554, 76420-254 +8Application ANDA064048, ANDA062452, ANDA064163
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 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 24208-580-60 | Bausch & Lomb | 11 May 1994 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 66267-971-05 | NuCare Pharmaceuticals | 16 March 2017 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 68071-3554-5 | NuCare Pharmaceuticals,Inc | 7 December 2023 |
| 5 mL in 1 box | 68071-4827-5 | NuCare Pharmaceuticals,Inc | 29 March 2019 |
| 5 mL in 1 carton | 61919-106-05 | Direct RX | 7 May 2015 |
| 5 mL in 1 bottle, dropper | 72189-359-05 | Direct_Rx | 17 June 2022 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 63187-560-05 | Proficient Rx | 1 December 2018 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 63187-764-05 | Proficient Rx | 1 November 2016 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 50090-0569-0 | A-S Medication Solutions | 29 June 2016 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 76420-254-05 | Asclemed | 19 July 2022 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 68788-8592-5 | Preferred Pharmaceuticals | 22 February 2024 |
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 3 mg/mL eye drops 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.