Prescription medicine
Tobramycin Brand names: Tobi, Tobrex, Kitabis, Bethkis; first approved as Nebcin
Tobramycin (Tobi) is a prescription medicine with an FDA approval on record since 1975. FDA's NDC Directory lists it from 40 generic labelers, and pharmacies paid $1.08 per mL (Tobramycin 300 mg/5 mL ampule) in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the tobramycin FDA label on DailyMed (effective November 1, 2023, Bausch & Lomb Incorporated); the NDA 50477 record on Drugs@FDA; every tobramycin label on DailyMed.
Highlights of the record
FDA label of November 1, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTobramycin ophthalmic solution, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria.
Forms and strengths
- 28 mg
- 1.2 g/30ml
- 3 mg/ml
- 3 mg/g
- 10 mg/ml
- 40 mg/ml
- 300 mg/5ml
- 300 mg/4ml
- 1200 mg/30ml
Solution; solution/ drops; injection; injection (powder) (lyophilized) for solution; injection (powder) for solution.
On the market
- Earliest approval on file
- June 11, 1975 Nebcin, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 51 first October 1, 1976; 28 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 46 of which 40 under generic applications, 5 under brand applications, repackagers included
- Last listed patent
- November 4, 2030 Tobi Podhaler powder; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.08 per mL Tobramycin 300 mg/5 mL ampule
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 8 since 2014 0 Class I among all firms' recalls; latest February 22, 2024; 7 more by firms not listed as its makers
- FAERS reports
- 24,368 through July 30, 2026
What is tobramycin used for?
From the label: indications and usageTobramycin ophthalmic solution, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution. Clinical studies have shown tobramycin to be safe and effective for use in children.
Conditions named in the indications of tobramycin's FDA labels, with every medicine labeled for each:
From other tobramycin labelsBacterial infections: INDICATIONS AND USAGE Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Urinary tract infections: Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp (indole-positive and indole-negative), E. coli, Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus, Providencia sp, and Citrobacter sp.
FDA pharmacologic class: Aminoglycoside Antibacterial.
Source: FDA drug label (Tobramycin), Bausch & Lomb Incorporated, effective November 1, 2023 (SPL set a5693ec9-d2f7-4d45-90b0-a113c54840d7), via openFDA; the full label on DailyMed
Is there a generic for tobramycin (Tobi)?
The FDA approved the first generic tobramycin on October 1, 1976. 51 generic applications are approved; 28 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 tobramycin from 40 labelers under a generic (ANDA) application and from 5 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 2 patents for Tobi Podhaler powder, the last expiring on November 4, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1975 earliest approval on file
- 1976 first generic approved
- 2030 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 tobramycin (Tobi)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.08 per mL (Tobramycin 300 mg/5 mL ampule), down 26% from $1.47 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 300 mg/5 mL ampule (generic)
- Tobrex 0.3% eye ointment (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tobramycin 0.3% eye drop | Generic | $1.11 per mL | n/a | +5% |
| Tobramycin 300 mg/5 mL ampule | Generic | $1.08 per mL | n/a | -26% |
| Tobramycin 80 mg/2 mL vial | Generic | $0.832 per mL | $1.66 per vial | +3% |
| Tobrex 0.3% eye ointment | Brand | $84.41 per gram | n/a | +10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is tobramycin in shortage?
No tobramycin presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated July 17, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Tobramycin Sulfate, Injection, 80 mg/2 mL (40 mg/mL); 2 mL Multiple Dose Glass Fliptop Vial (NDC 0409-3578-01) | Hospira, Inc., a Pfizer Company | To Be Discontinued | July 17, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has tobramycin been recalled?
The FDA's Enforcement Report lists 15 recalls naming tobramycin since 2014: 0 Class I (the most serious), 14 Class II, 1 Class III; 6 still ongoing. 7 of them are by firms that FDA's NDC Directory does not list as a maker of tobramycin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 22, 2024 | Class II | Eugia US LLC | Failed Stability Specification: Water determination was found not complying with specification. |
| July 27, 2023 | Class III | ALEMBIC PHARMACEUTICALS, INC. | Failed Impurities/Degradation Specifications |
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| December 27, 2022 | Class II | Sentara Infusion Services | Lack of sterility assurance |
| October 13, 2022 | Class II | Akorn, Inc. | CGMP Deviations: |
| February 12, 2016 | Class II | Walter's Pharmacy | Lack of Assurance of Sterility |
| November 10, 2015 | Class II | Walgreens Infusion Services not a listed maker | Lack of Assurance of Sterility |
| September 18, 2015 | Class II | Sentara Enterprises | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tobramycin label say about other medicines?
The tobramycin label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name tobramycin. 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 |
|---|---|---|
| Dornase alfa | drug interactions | In clinical studies, patients receiving TOBI Podhaler continued to take dornase alfa, bronchodilators, inhaled corticosteroids, and macrolides. |
| Ethacrynic acid | drug interactions | Concomitant administration with ethacrynic acid, furosemide, urea, or intravenous mannitol is not recommended due to possible enhancement of aminoglycoside toxicity. |
| Furosemide | drug interactions | Concomitant administration with ethacrynic acid, furosemide, urea, or intravenous mannitol is not recommended due to possible enhancement of aminoglycoside toxicity. |
| Streptomycin | warnings and precautions | Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. |
Other labels that name tobramycin
Source: FDA drug label (Tobramycin), Bausch & Lomb Incorporated, effective November 1, 2023 (SPL set a5693ec9-d2f7-4d45-90b0-a113c54840d7), via openFDA; the full label on DailyMed
What do FAERS reports show for tobramycin?
The FDA Adverse Event Reporting System holds 24,368 reports that list tobramycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,885 are coded as a death and 11,583 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 else is labeled for the same conditions as tobramycin?
8 other medicines are given the same way (ophthalmic) and in the same FDA class as tobramycin or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (ophthalmic) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dexamethasone and neomycin and polymyxin b | Bacterial infections | 9 labelers | $1.78 per mL Neomyc-polym-dexameth eye drop | No current entry |
| Gentamicin | Bacterial infections | 10 labelers | $0.790 per mL 0.3% eye drop | No current entry |
| Bacitracin, hydrocortisone, neomycin and polymyxin b | Bacterial infections | 1 labeler | $5.52 per gram Neo-bacit-poly-hc eye ointment | No current entry |
| Hydrocortisone and neomycin and polymyxin b | Bacterial infections | 1 labeler | $17.64 per mL Neomycin-poly-hc eye drops | No current entry |
| Ofloxacin | Bacterial infections | 23 labelers | $1.24 per mL 0.3% eye drops | No current entry |
| Polymyxin b and trimethoprim | Bacterial infections | 10 labelers | $0.452 per mL Polymyxin b-tmp eye drops | No current entry |
| Sulfacetamide | Bacterial infections | 6 labelers | $1.96 per mL 10% eye drops | No current entry |
| Azithromycin | Bacterial infections | none listed | $98.51 per mL 1% eye drops | A presentation being discontinued |
Every medicine labeled for the same conditions as tobramycin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tobramycin compare with medicines for the same use?
6 side-by-side pages set tobramycin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tobramycin
- 8 medicines for the same use
- Other aminoglycoside antibacterials
- the pharmacologic class, with prices and generics
- Tobramycin side effects
- the label's list beside FAERS reports
- Tobramycin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other