Prescription medicine
Dexamethasone and tobramycin Brand names: Tobradex
Dexamethasone and tobramycin (Tobradex) is a prescription medicine with an FDA approval on record since 1988. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $4.18 per mL (Tobramycin-dexameth eye suspension) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $46.63 per mL (Tobradex st 0.3-0.05% eye drop).
- Generic listed
Check it at the source: the dexamethasone and tobramycin FDA label on DailyMed (effective April 7, 2025, Sandoz Inc); the NDA 50592 record on Drugs@FDA; every dexamethasone and tobramycin label on DailyMed.
Highlights of the record
FDA label of April 7, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Forms and strengths
- 3 mg/ml / 1 mg/ml
- 3 mg/ml / 0.5 mg/ml
- 3 mg/g / 1 mg/g
Suspension/ drops; ointment.
On the market
- Earliest approval on file
- August 18, 1988 Tobradex, Sandoz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first October 27, 1999; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 8 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- August 3, 2028 Tobradex St suspension/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $4.18 per mL Tobramycin-dexameth eye suspension
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2022 0 Class I among all firms' recalls; latest April 13, 2022
- FAERS reports
- 3,408 through July 30, 2026
What is dexamethasone and tobramycin used for?
From the label: indications and usageTobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. […]
FDA pharmacologic class: Aminoglycoside Antibacterial and Corticosteroid.
Source: FDA drug label (Tobramycin and Dexamethasone), Sandoz Inc, effective April 7, 2025 (SPL set 05fd0c36-39b4-4a43-8490-eb8dfc0920ae), via openFDA; the full label on DailyMed
Is there a generic for dexamethasone and tobramycin (Tobradex)?
The FDA approved the first generic dexamethasone and tobramycin on October 27, 1999. 3 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dexamethasone and tobramycin from 8 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Tobradex suspension/drops; a patent listed only for Tobradex St suspension/drops runs to August 3, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1988 earliest approval on file
- 1999 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dexamethasone and tobramycin (Tobradex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $4.18 per mL (Tobramycin-dexameth eye suspension), down 8% from $4.54 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tobramycin-dexameth eye suspension (generic)
- Tobradex st 0.3-0.05% eye drop (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tobramycin-dexameth eye suspension | Generic | $4.18 per mL | n/a | -8% |
| Tobradex eye ointment | Brand | $89.71 per gram | n/a | +10% |
| Tobradex st 0.3-0.05% eye drop | Brand | $46.63 per mL | n/a | -0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dexamethasone and tobramycin been recalled?
The FDA's Enforcement Report lists 1 recall naming dexamethasone and tobramycin since 2022: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dexamethasone and tobramycin label say about other medicines?
The dexamethasone and tobramycin label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Benzalkonium | warnings and precautions | Contact Lens Use TOBRADEX ST contains benzalkonium chloride, an antimicrobial preservative, that may be absorbed by soft contact lenses. |
| Fluorescein | warnings and precautions | The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. |
Source: FDA drug label (Tobramycin and Dexamethasone), Sandoz Inc, effective April 7, 2025 (SPL set 05fd0c36-39b4-4a43-8490-eb8dfc0920ae), via openFDA; the full label on DailyMed
What do FAERS reports show for dexamethasone and tobramycin?
The FDA Adverse Event Reporting System holds 3,408 reports that list dexamethasone and tobramycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 153 are coded as a death and 892 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other aminoglycoside antibacterials
- the pharmacologic class, with prices and generics
- Dexamethasone and tobramycin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other