Medicine
TobraDex 1 mg/3 mg per g eye ointment
TobraDex 1 mg/3 mg per g eye ointment is a prescription medicine containing Dexamethasone and Tobramycin for ophthalmic use, marketed by Novartis Pharmaceuticals, 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 2°C to 25°C (36°F to 77°F).
Key facts
- Active ingredient (INN)
- Dexamethasone and Tobramycin
- Brand
- TobraDex
- Strength
- 1 mg/3 mg per g
- Dosage form
- Eye ointment
- Route
- Ophthalmic
- Packs
- 3.5 g
- Marketing authorisation holder
- Novartis Pharmaceuticals
- Manufacturer
- Novartis Pharmaceuticals
- 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
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 October 1988
- Identifiers
- RxCUI 208821, 309682DailyMed set ID 7f310e0e-0d3b-493d-b6c4-238493a2a9b9NDC 0078-0876Application NDA050616
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 |
|---|---|---|---|
| 3.5 g in 1 tube | 0078-0876-01 | Novartis Pharmaceuticals | 27 October 2020 |
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 18 August 1988 | 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 Dexamethasone and Tobramycin
Clinical summary
Dexamethasone and Tobramycin is a fixed-dose combination of an aminoglycoside antibacterial and a corticosteroid. It is available as ophthalmic suspension and eye ointment. MedsAcross supplies Dexamethasone and 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 Dexamethasone and TobramycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tobramycin and Dexamethasone prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
Need TobraDex 1 mg/3 mg per g eye 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.