Medicine
Dexamethasone and Tobramycin 1 mg/3 mg per mL ophthalmic suspension
Dexamethasone and Tobramycin 1 mg/3 mg per mL ophthalmic suspension is a generic prescription medicine for ophthalmic use, made by 12 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 8°C to 27°C (46°F to 80°F). Store suspension upright and shake well…
Key facts
- Active ingredient (INN)
- Dexamethasone and Tobramycin
- Brand
- Sold under the generic name
- Strength
- 1 mg/3 mg per mL
- Dosage form
- Ophthalmic suspension
- Route
- Ophthalmic
- Packs
- 1 bottle, 2.5 mL, 5 mL and 30 more
- Manufacturers
- Bryant Ranch PrepackA-S Medication SolutionsBausch & LombNuCare Pharmaceuticals,IncPadagisSandozSportpharmAdvanced Rx of TennesseeAdvanced Rx Pharmacy of TennesseePreferred Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 8°C to 27°C (46°F to 80°F). Store suspension upright and shake well before using.
- 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
- 27 October 1999
- Identifiers
- RxCUI 309683DailyMed set ID 15280680-edc0-4e5d-99ee-117a6f589307, cdd9086d-821f-4ac8-bc49-f1869dffb150, 3dd00c21-ae42-0613-e063-6394a90a8012 +22NDC 71335-2854, 50090-1914, 67296-2174 +21Application ANDA212715, ANDA064134, NDA050592
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 | 24208-295-05 | Bausch & Lomb | 27 October 1999 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 24208-295-10 | Bausch & Lomb | 27 October 1999 |
| 1 bottle, dropper in 1 carton / 2.5 mL in 1 bottle, dropper | 24208-295-25 | Bausch & Lomb | 27 October 1999 |
| 1 bottle, plastic in 1 carton / 5 mL in 1 bottle, plastic | 0574-4031-05 | Padagis | 17 March 2022 |
| 1 bottle, plastic in 1 carton / 10 mL in 1 bottle, plastic | 0574-4031-10 | Padagis | 17 March 2022 |
| 1 bottle, plastic in 1 carton / 2.5 mL in 1 bottle, plastic | 0574-4031-25 | Padagis | 17 March 2022 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 61314-647-05 | Sandoz | 2 January 2015 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 61314-647-10 | Sandoz | 2 January 2009 |
| 1 bottle in 1 carton / 2.5 mL in 1 bottle | 61314-647-25 | Sandoz | 2 January 2009 |
| 2.5 mL in 1 bottle, plastic | 63629-9570-1 | Bryant Ranch Prepack | 21 December 2022 |
| 5 mL in 1 bottle, plastic | 63629-9571-1 | Bryant Ranch Prepack | 21 December 2022 |
| 10 mL in 1 bottle, plastic | 63629-9572-1 | Bryant Ranch Prepack | 21 December 2022 |
| 5 mL in 1 bottle, plastic | 71335-2840-1 | Bryant Ranch Prepack | 21 October 2025 |
| 2.5 mL in 1 bottle, plastic | 71335-2854-1 | Bryant Ranch Prepack | 21 October 2025 |
| 10 mL in 1 bottle, plastic | 71335-2891-1 | Bryant Ranch Prepack | 21 October 2025 |
| 10 mL in 1 bottle, plastic | 72162-1128-2 | Bryant Ranch Prepack | 24 December 2024 |
| 5 mL in 1 bottle, plastic | 72162-1128-4 | Bryant Ranch Prepack | 24 December 2024 |
| 2.5 mL in 1 bottle, plastic | 72162-1128-7 | Bryant Ranch Prepack | 24 December 2024 |
| 2.5 mL in 1 bottle | 50090-1135-0 | A-S Medication Solutions | 28 November 2014 |
| 5 mL in 1 bottle | 50090-1136-0 | A-S Medication Solutions | 28 November 2014 |
| 1 bottle, dropper in 1 carton / 2.5 mL in 1 bottle, dropper | 50090-1914-0 | A-S Medication Solutions | 2 July 2015 |
| 5 mL in 1 bottle, plastic | 50090-7267-0 | A-S Medication Solutions | 7 October 2024 |
| 1 bottle, plastic in 1 carton / 2.5 mL in 1 bottle, plastic | 50090-8046-0 | A-S Medication Solutions | 3 September 2026 |
| 1 bottle, dropper in 1 carton / 2.5 mL in 1 bottle, dropper | 68071-1821-2 | NuCare Pharmaceuticals,Inc | 30 December 2020 |
| 1 bottle, dropper in 1 carton / 2.5 mL in 1 bottle, dropper | 68071-2418-2 | NuCare Pharmaceuticals,Inc | 26 May 2021 |
| 5 mL in 1 box | 68071-4203-5 | NuCare Pharmaceuticals,Inc | 28 December 2017 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 85766-188-05 | Sportpharm | 20 March 2026 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 85766-188-10 | Sportpharm | 2 July 2026 |
| 5 mL in 1 bottle | 80425-0366-1 | Advanced Rx of Tennessee | 2 November 2023 |
| 5 mL in 1 bottle, plastic | 80425-0260-1 | Advanced Rx Pharmacy of Tennessee | 15 February 2023 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 68788-4081-5 | Preferred Pharmaceuticals | 26 February 2026 |
| 5 mL in 1 bottle, plastic | 67296-2174-5 | Redpharm Drug | 17 March 2022 |
| 5 mL in 1 bottle | 70518-3994-0 | Remedyrepack | 24 January 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 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 Dexamethasone and Tobramycin 1 mg/3 mg per mL ophthalmic suspension 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.