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Medicine

Tobramycin 3 mg/mL ophthalmic solution

Tobramycin · Ophthalmic
Available on requestPrescription onlyUS FDAGeneric name

Tobramycin 3 mg/mL ophthalmic solution is a generic prescription medicine for ophthalmic 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 2°C to 25°C (36°F to 77°F).

Key facts

Active ingredient (INN)
Tobramycin
Brand
Sold under the generic name
Strength
3 mg/mL
Dosage form
Ophthalmic solution
Route
Ophthalmic
Packs
1 bottle, 5 mL and 7 more
Manufacturers
Proficient RxA-S Medication SolutionsAdvanced Rx Pharmacy of TennesseeAsclemedBausch & LombNuCare Pharmaceuticals,IncPreferred PharmaceuticalsSandozSportpharm
Origin register
US FDA, United States
Storage
Store at 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
J01GB01 Tobramycin
HS code (indicative)
3004.20Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
29 November 1993
Identifiers
RxCUI 313415DailyMed set ID c6f9c6b1-2c45-4f6b-a1fb-e55d74fc04c3, 27e2c16e-19b0-4745-93eb-5cf99f94bb92, d8235017-cb52-44d4-a6e6-6ee3f00c47d2 +7NDC 76420-791, 61314-643, 63187-024 +7Application ANDA064052, ANDA062535

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.

PackCodeLabelerMarketed since
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper24208-290-05Bausch & Lomb29 November 1993
5 mL in 1 bottle, plastic61314-643-05Sandoz9 January 1995
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper63187-024-05Proficient Rx1 November 2018
5 mL in 1 bottle, plastic63187-973-05Proficient Rx1 January 2018
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper50090-2127-0A-S Medication Solutions15 October 2015
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper80425-0341-1Advanced Rx Pharmacy of Tennessee24 May 2023
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper76420-791-05Asclemed20 March 2024
5 mL in 1 box66267-936-05NuCare Pharmaceuticals,Inc8 September 2017
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper68788-4149-5Preferred Pharmaceuticals15 July 2026
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper85766-025-05Sportpharm5 August 2025

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 11 June 1975Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS 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 Tobramycin

Clinical summary

Tobramycin is an aminoglycoside antibacterial indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. It is available as inhalation solution, eye drops and injection for ophthalmic and intravenous use. MedsAcross supplies Tobramycin 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 Tobramycin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Tobramycin 3 mg/mL ophthalmic solution 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.