Medicine
Tobramycin 300 mg/5 mL inhalant
Tobramycin 300 mg/5 mL inhalant is a generic prescription medicine for inhalation use, made by 3 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Tobramycin inhalation solution, USP should be stored under refrigeration at…
Key facts
- Active ingredient (INN)
- Tobramycin
- Brand
- Sold under the generic name
- Strength
- 300 mg/5 mL
- Dosage form
- Inhalant
- Route
- Inhalation
- Packs
- 14 pouches, 56 pouches
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaMicro LabsIndia3 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Tobramycin inhalation solution, USP should be stored under refrigeration at 2ºC to 8ºC or 36ºF to 46ºF. Upon removal from the refrigerator, or if refrigeration is unavailable, tobramycin inhalation solution, USP pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days.
- Cold chain
- Yes, shipped temperature controlled
- 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
- 14 May 2019
- Identifiers
- RxCUI 348719DailyMed set ID 3d044738-a715-fdee-7849-521e8981e6ec, 9d8b7b6c-3072-48e9-87c8-51160b9df9bc, e5bbf589-d066-c89a-c40f-cbeb6f98c5b5NDC 16714-119, 42571-408, 43598-605Application ANDA207080, ANDA217344
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 |
|---|---|---|---|
| 14 pouch in 1 carton / 4 ampule in 1 pouch / 5 mL in 1 ampule | 43598-605-56 | Dr. Reddy's LaboratoriesIndia | 14 May 2019 |
| 56 pouch in 1 carton / 1 ampule in 1 pouch / 5 mL in 1 ampule | 43598-605-58 | Dr. Reddy's LaboratoriesIndia | 29 October 2020 |
| 14 pouch in 1 carton / 4 ampule in 1 pouch / 5 mL in 1 ampule | 42571-408-92 | Micro LabsIndia | 1 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.
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 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
- TOBREX prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Tobi Podhaler: European public assessment report (EPAR) · European Medicines Agency
- Vantobra (previously Tobramycin PARI): European public assessment report (EPAR) · European Medicines Agency
Need Tobramycin 300 mg/5 mL inhalant 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.