Tobramycin 3 mg/mL Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Aminoglycoside Antibacterial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Ophthalmic tobramycin is used to treat eye infections. Tobramycin is in a class of medications called antibiotics. It works by killing bacteria that cause infections.
Read the full MedlinePlus article ↗- Tobramycin is an antibiotic, but the form you have determines exactly what it treats. If you're inhaling it through a nebulizer or using the TOBI Podhaler device, it's being used t...
- That on-off cycle is by design. Inhaling tobramycin for 28 days helps knock back the Pseudomonas bacteria in your lungs, and then the 28-day break gives your body a rest and helps...
- Why do I have to take the inhaled form for 28 days and then stop for 28 days?
- Absolutely not — this is really important. The TOBI Podhaler capsules must never be swallowed. The medicine only works when it's inhaled directly into your lungs using the Podhaler...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Tobramycin — tap one for details:
Tobramycin may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII R57ZHV85D4
Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 0YPR65R21J
Sodium sulfate is a mineral salt used in pharmaceuticals as a filler and diluent. It helps provide bulk and stability to tablets and capsules while remaining inert in the body.
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UNII O40UQP6WCF
A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.
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UNII Y27PUL9H56
Tyloxapol is a synthetic detergent and surfactant used in medications as a solubilizer and emulsifier. It helps dissolve or blend ingredients that don't naturally mix well, improving how the medicine disperses in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.9370 | $4.69 / 5 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tobramycin 3 mg/mL 24208-0290-05 | Bausch | 1 bottle | $1.158 | AT | Availability likely | — |
| Tobramycin 3 mg/mL 61314-0643-05 | Sandoz | 5 ml | $1.158 | AT | Availability likely | — |
| Tobramycin Ophthalmic Solution 3 mg/mL 62332-0518-05 | Alembic | 1 bottle | $1.158 | AT | Availability likely | — |
| Tobramycin 3 mg/mL 70069-0131-01 | Somerset | 1 bottle | $1.158 | AT | Availability likely | — |
| Tobramycin Ophthalmic Solution 3 mg/mL 46708-0518-05 | Alembic | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 50090-2127-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 50090-4190-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 60760-0583-05 | St. | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 61919-0642-05 | DirectRX | 5 ml | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 62250-0110-01 | Belcher | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 63187-0024-05 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 63187-0902-02 | Proficient | 1 bottle | — | — | FDA listed | — |
| Tobramycin 3 mg/mL 63187-0973-05 | Proficient | 5 ml | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 66267-0936-05 | NuCare | 5 ml | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 68071-2272-05 | NuCare | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 68083-0374-01 | Gland | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 68788-7252-05 | Preferred | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 70518-1370-00 | REMEDYREPACK | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 71205-0101-05 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 76420-0092-05 | Asclemed | 5 ml | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 76420-0791-05 | Asclemed | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mLthis 80425-0341-01 | Advanced | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 85766-0025-05 | Sportpharm | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 85766-0189-05 | Sportpharm | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 86211-0110-01 | JVET | 1 bottle | — | AT | FDA listed | — |
| Tobramycin 3 mg/mL 68788-4149-05 | Preferred | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 80425-0341-01 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (80425-0341-1) / 5 mL in 1 BOTTLE, DROPPER | 2023-05-24 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Tobramycin 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION In mild to moderate disease, instill 1 or 2 drops into the affected eye(s) every 4 hours. In severe infections, instill 2 drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation. FOR TOPICAL OPHTHALMIC USE ONLY DO NOT USE
⛔ Contraindications ▾
CONTRAINDICATIONS Tobramycin ophthalmic solution, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.
⚠️ Warnings ▾
WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE . Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction to tobramycin ophthalmic solution, 0.3% occurs, discontinue use.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The most frequent adverse reactions to tobramycin ophthalmic solution, 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with tobramycin ophthalmic solution. Postmarketing Experience Additional adverse reactions identified from postmarketing use include anaphylactic reaction, Stevens-Johnson syndrome, and erythema multiforme.
The following additional adverse reactions have been reported with systemic aminoglycosides: Neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, because of their potential effect on neuromuscular function. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Pregnancy Reproduction studies in 3 types of animals at doses up to 33 times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 months has not been established.
🧓 Geriatric Use ▾
Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY In Vitro Data: In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci , including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci , including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.
Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Tobramycin Ophthalmic Solution USP, 0.3% is supplied in a plastic bottle with a controlled drop tip and a white polypropylene cap in the following size: 5 mL fill in a 10 mL bottle NDC 80425-0341-01 Storage Store at 2° to 25°C (36° to 77°F). Avoid excessive heat. After opening, Tobramycin Ophthalmic Solution USP, 0.3% can be used until the expiration date on the bottle.
Distributed by: Advanced Rx of Tennessee, LLC Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2021 Bausch & Lomb Incorporated or its affiliates Revised: June 2021 9116807 (folded) 9116907 (flat)
📋 Description ▾
DESCRIPTION Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL contains: Active: tobramycin 3 mg (0.3%). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol and purified water.
Sodium hydroxide and/or sulfuric acid (to adjust pH). Tobramycin ophthalmic solution, 0.3% has a pH range between 7.0 and 8.0. Preservative Added: benzalkonium chloride 0.1 mg (0.01%).
Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is: Chemical name: (2S,3R,4S,5S,6R)-4-amino-2-[(1S,2S,3R,4S,6R)-4,6-diamino-3-[(2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxyoxan-2-yl]oxy-2-hydroxycyclohexyl]oxy-6-(hydroxymethyl)oxane-3,5-diol CHEM
💬 Information for Patients ▾
Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution.