TOBRAMYCIN AND DEXAMETHASONE 3 mg/mL; 1 mg/mL Suspension/ Drops, 5 mL
🆔 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
- It's doing both at once. The dexamethasone in this product is a steroid that calms inflammation — redness, swelling, and discomfort in the eye. The tobramycin is an antibiotic that...
- What exactly is this eye drop treating — is it for an infection or inflammation?
- For the eye drops — tilt your head back, gently pull down your lower eyelid to create a small pocket, and instill the drops into that pocket (not directly onto your eyeball). Try n...
- How do I put in the eye drops or ointment correctly?
Patient education
Supplement & herbal interactions
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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 F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII S38J6RZN16
Hydroxyethyl cellulose is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust product texture, and a film-former to create smooth coatings on tablets.
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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.
9 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?
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💲 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 | $7.73 | $38.67 / 5 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 00574-4031-05 | Padagis | 5 ml | $4.268 | AB | Availability likely | — |
| Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 24208-0295-05 | Bausch | 1 bottle | $4.268 | AB | Availability likely | — |
| Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 61314-0647-05 | Sandoz | 5 ml | $4.268 | AB | Availability likely | — |
| Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 50090-1135-00 | A-S | 2.5 ml | — | AB | FDA listed | — |
| Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 50090-1136-00 | A-S | 5 ml | — | AB | FDA listed | — |
| Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 50090-1914-00 | A-S | 1 bottle | — | AB | FDA listed | — |
| Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 50090-7267-00 | A-S | 5 ml | — | AB | FDA listed | — |
| Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 63629-9570-01 | Bryant | 2.5 ml | — | AB | FDA listed | — |
| Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 63629-9571-01 | Bryant | 5 ml | — | AB | FDA listed | — |
| Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 63629-9572-01 | Bryant | 10 ml | — | AB | FDA listed | — |
| Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 67296-2174-05 | Redpharm | 5 ml | — | AB | FDA listed | — |
| Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 68071-1821-02 | NuCare | 1 bottle | — | AB | FDA listed | — |
| Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 68071-2418-02 | NuCare | 1 bottle | — | AB | FDA listed | — |
| Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 68071-4203-05 | NuCare | 5 ml | — | AB | FDA listed | — |
| Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 68788-4081-05 | Preferred | 1 bottle | — | AB | FDA listed | — |
| Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 70518-3994-00 | REMEDYREPACK | 5 ml | — | AB | FDA listed | — |
| Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mLthis 71335-2840-01 | Bryant | 5 ml | — | AB | FDA listed | — |
| Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 71335-2854-01 | Bryant | 2.5 ml | — | AB | FDA listed | — |
| Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 71335-2891-01 | Bryant | 10 ml | — | AB | FDA listed | — |
| Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 72162-1128-02 | Bryant | 10 ml | — | AB | FDA listed | — |
| Tobramycin and dexamethasone 3 mg/mL; 1 mg/mL 80425-0260-01 | Advanced | 5 ml | — | AB | FDA listed | — |
| Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 80425-0366-01 | Advanced | 5 ml | — | AB | FDA listed | — |
| Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 85766-0188-05 | Sportpharm | 1 bottle | — | AB | 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?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71335-2840-01 You're viewing this | 5 mL in 1 BOTTLE, PLASTIC (71335-2840-1) | 2025-10-21 | 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 | — Not published for this NDC No photo available yet for this listing. |
| 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
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Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Tobramycin 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. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs.
Care should be taken not to discontinue therapy prematurely. Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
⛔ Contraindications ▾
CONTRAINDICATIONS: Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.
⚠️ Warnings ▾
WARNINGS: FOR TOPICAL OPHTHALMIC USE. 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 reaction, or bullous reactions. If a sensitivity reaction does occur, discontinue use. Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.
Intraocular pressure (IOP) should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions and parasitic infections of the eye, steroids may mask infection or enhance existing infection.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available. The most frequent adverse reactions to topical ocular tobramycin (tobramycin ophthalmic solution) are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema.
These reactions occur in less than 4% of patients. The reactions due to the steroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials.
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.
Postmarketing Experience: Additional adverse reactions identified from post-marketing use include anaphylactic reaction, erythema multiforme. The following additional adverse reactions have been reported with the individual components listed below: Dexamethasone : Cushing's syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors. 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 Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Pregnancy: Corticosteroids have been found to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy.
Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation.
Tobramycin and dexamethasone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 years have 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: Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant. Dexamethasone is a potent corticoid.
The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that 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. No data are available on the extent of systemic absorption from tobramycin and dexamethasone ophthalmic suspension; however, it is known that some systemic absorption can occur with ocularly applied drugs.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Tobramycin and dexamethasone ophthalmic suspension, USP is sterile ophthalmic suspension supplied as a 5 mL suspension in a 10 mL natural polyethylene bottle respectively with a natural polyethylene controlled drop tip and a white polypropylene cap. NDC: 71335-2840-1: 5 mL in a Bottle STORAGE: Store at 8°C to 27°C (46°F to 80°F). Store suspension upright and shake well before using.
After opening, tobramycin and dexamethasone ophthalmic suspension can be used until the expiration date on the bottle. Rx Only Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
DESCRIPTION: Tobramycin and dexamethasone ophthalmic suspension USP is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use with a pH of approximately 5.5 and an osmolality of approximately 300 mOsm/kg. The chemical structures for tobramycin and dexamethasone are presented below: Tobramycin Empirical Formula: C 18 H 37 N 5 O 9 Chemical Name: O -3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O -[2,6-diamino-2,3,6-trideoxy-α-D- ribo -hexopyranosyl-(1→6)]-2-deoxy-L-streptamine MW: 467.52 Dexamethasone Empirical Formula: C 22 H 29 FO 5 Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione MW: 392.47 Each mL of Tobramycin and dexamethasone ophthalmic suspension contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg).
Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium dihydrate, hydroxyethyl cellulose, sodium chloride, sodium sulfate anhydrous, sulfuric acid and/or sodium hydroxide (to adjust pH), tyloxapol, and water for injection.
💬 Information for Patients ▾
Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the contents. Contact lenses should not be worn during the use of this product.