Tobramycin
Tobramycin is an aminoglycoside antibiotic used as an inhaled medicine for Pseudomonas aeruginosa lung infection in cystic fibrosis, as eye drops or ointment for external eye infections, and as an injection for serious bacterial infections.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 30 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Tobramycin is an aminoglycoside antibiotic that kills bacteria by disrupting how they make proteins. It is used inhaled for Pseudomonas lung infection in cystic fibrosis (a long-standing mainstay), as eye drops or ointment for external eye infections, and by injection for serious infections; it has been on the market since about 1981 and is available as a generic. When inhaled, it is usually manageable, and the effects people notice most are cough, sore throat and a hoarse voice. Watch for ringing in the ears, hearing loss, dizziness or balance trouble, because like other aminoglycosides it can harm hearing, balance, kidneys and muscles.
Clinical pearls
- Get help promptly if wheezing or chest tightness (bronchospasm, airway tightening) comes on right after an inhaled dose.
- Make sure every prescriber knows you use it, since water pills like furosemide or ethacrynic acid raise its toxicity.
- Before surgery, tell the anesthesia team, because the muscle-relaxing drugs they use can prolong breathing paralysis with tobramycin.
- Mention any maternal relative who lost hearing from an aminoglycoside, or a known mitochondrial DNA variant, before starting.
Patient information guide A plain-language walkthrough of Tobramycin, written from its FDA label.
What Tobramycin is used for
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Tobramycin is an antibiotic with different uses depending on the product.
- Inhaled products (Tobi, Kitabis Pak, Bethkis, TOBI Podhaler and tobramycin inhalation solutions): manage cystic fibrosis in patients with Pseudomonas aeruginosa.
- Tobrex ointment and tobramycin ophthalmic solution: treat external eye infections caused by susceptible bacteria.
- Tobramycin injection: treats serious bacterial infections such as septicemia (bloodstream infection), lower respiratory tract infections, meningitis, intra-abdominal infections, skin, bone and skin structure infections, and complicated urinary tract infections.
How Tobramycin works
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Tobramycin is an aminoglycoside antibiotic. It disrupts how bacteria build proteins. That damages the bacterial cell envelope and kills the cell.
It works against many gram-negative bacteria, including Pseudomonas aeruginosa. Bacteria can become less sensitive over time, and resistance to other aminoglycosides can overlap.
Tobramycin dosage
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Inhaled tobramycin is breathed in by mouth, usually twice daily, in cycles of 28 days on and 28 days off. Doses should be about 12 hours apart and not less than 6 hours apart. For some nebulizer products, a missed dose can be taken up to 6 hours before the next one.
- Eye products are used in the affected eye, more often for severe infections.
- Injections are given into a vein or muscle by a healthcare professional.
Always follow your prescriber and the product label.
Dosing details from the FDA-approved label
From the Tobramycin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults and pediatric patients 6 years of age and older (Tobramycin Inhalation Solution / TOBI)
- One single-dose ampule (300 mg) twice daily by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug
- Doses as close to 12 hours apart as possible, but not less than 6 hours apart
- Dosage is not adjusted by weight; all patients receive 300 mg twice daily
- KITABIS PAK (tobramycin inhalation solution co-packaged with PARI LC PLUS Reusable Nebulizer)
- One single-use ampule (300 mg/5 mL) twice a day by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug
- Doses as close to 12 hours apart as possible, not less than 6 hours apart
- Same dose for all patients regardless of age or weight
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2.1 ) The recommended dosage for adults and pediatric patients 6 years of age and older is one single-dose ampule (300 mg) twice daily by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug . ( 2.1 ) Dosage is not adjusted by weight. ( 2.1 ) Take doses as close to 12 hours apart as possible; but not less than 6 hours apart. ( 2.1 ) Administer each 300 mg dose by inhalation using a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide compressor. ( 2.2 ) 2.1 Dosage Tobramycin inhalation solution is for oral inhalation only [see Dosage and Administration ( 2.2 ) ]. The recommended dosage of tobramycin inhalation solution for both adults and pediatric patients 6 years of age and older is one single-dose ampule (300 mg) administered twice daily for 28 days. Dosage is not adjusted by weight. All patients should be administered 300 mg twice daily. Tobramycin inhalation solution is administered twice daily in alternating periods of 28 days. After 28 days of therapy, patients should stop tobramycin inhalation solution therapy for the next 28 days, and then resume therapy for the next 28 day on/28 day off cycle. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart. If patients miss a dose, they should take it as soon as possible anytime up to 6 hours prior to their next scheduled dose. If less than 6 hours remain before the next dose, wait until their next scheduled dose. 2.2 Administration Instructions Tobramycin inhalation solution is administered by oral inhalation over an approximately 15-minute period, using a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide compressor. Tobramycin inhalation solution should not be diluted or mixed with dornase alfa or other medications in the nebulizer. Tobramycin inhalation solution is not for subcutaneous, intravenous or intrathecal administration. Prior to administration of tobramycin inhalation solution, read the Patient Information/Instructions for Use for tobramycin inhalation solution for detailed information on how to use tobramycin inhalation solution and follow the manufacturer’s instructions for use and care of the PARI LC PLUS Reusable Nebulizer and DeVilbiss Pulmo-Aide air compressor.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Tobramycin side effects
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Inhaled tobramycin commonly causes breathing-related effects.
Common side effects
- Cough
- Productive cough (bringing up mucus)
- Shortness of breath
- Fever
- Sore throat
- Hoarse or changed voice
- Coughing up blood
- Headache
- Lung disorder and shortness of breath
- Sore throat and hoarseness
When to get medical help
- Call your doctor if you have ringing in the ears, hearing loss, dizziness, vertigo or balance problems.
- Get help if you have wheezing or tightness in the chest (bronchospasm) after inhaling a dose.
- Tell your doctor about new or worsening muscle weakness or breathing trouble.
- Report any signs of kidney problems promptly.
Tobramycin warnings and precautions
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- Hearing and balance: ringing in the ears, hearing loss, vertigo or dizziness can occur. Some people with certain mitochondrial DNA variants are at higher risk.
- Bronchospasm: airway tightening can occur with inhalation.
- Kidneys: aminoglycosides can harm the kidneys, so monitoring is needed in those at risk.
- Muscles: can worsen weakness, especially in myasthenia gravis or Parkinson's disease.
- Pregnancy: aminoglycosides can cause fetal harm.
Tobramycin interactions
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Several drugs can add to tobramycin's toxicity.
- Other drugs harmful to nerves, kidneys or hearing: avoid using them together or in sequence.
- Ethacrynic acid, furosemide, urea or intravenous mannitol: not recommended because they can increase toxicity.
- Other aminoglycoside injections: need monitoring for toxicity and blood levels.
- Neuromuscular blocking agents: may increase the risk of prolonged respiratory paralysis.
Interactions listed in the FDA-approved label
From the Tobramycin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Other drugs with neurotoxic, nephrotoxic, or ototoxic potential: Concurrent and/or sequential use with tobramycin inhalation solution is addressed as a concern because of neurotoxic, nephrotoxic, or ototoxic potential. Should be avoided
- Ethacrynic acid: Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Should not be administered concomitantly
- Furosemide: Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Should not be administered concomitantly
- Urea: Can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Should not be administered concomitantly
- Intravenous mannitol: Can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Should not be administered concomitantly
- Inhaled mannitol: The interaction between inhaled mannitol and tobramycin inhalation solution has not been evaluated.
Read the label’s full interactions text
7 DRUG INTERACTIONS Concurrent and/or sequential use of tobramycin inhalation solution with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided ( 7.1 ). Concomitant administration with ethacrynic acid, furosemide, urea, or intravenous mannitol is not recommended due to possible enhancement of aminoglycoside toxicity ( 7.2 ). 7.1 Drugs with Neurotoxic, Nephrotoxic or Ototoxic Potential Concurrent and/or sequential use of tobramycin inhalation solution with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. 7.2 Diuretics Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Tobramycin inhalation solution should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and tobramycin inhalation solution has not been evaluated.
7.1 Drugs with Neurotoxic, Nephrotoxic or Ototoxic Potential Concurrent and/or sequential use of tobramycin inhalation solution with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided.
7.2 Diuretics Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Tobramycin inhalation solution should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and tobramycin inhalation solution has not been evaluated.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Tobramycin
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- Do not use if you are allergic to any aminoglycoside.
- Tell your doctor about hearing or balance problems, kidney disease, or neuromuscular disorders.
- Tell your doctor about pregnancy or plans for it. Absorption after inhalation is expected to be minimal, but risk to the baby is possible.
- If breastfeeding, watch the baby for loose or bloody stools and thrush.
- Inhaled products are not established under age 6.
- Older adults may need kidney monitoring.
Tobramycin overdose
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Too much tobramycin can cause dizziness, ringing in the ears, vertigo, loss of high-pitched hearing, breathing failure, muscle weakness and kidney problems. Inhaled tobramycin is absorbed poorly, and swallowing it is not significantly absorbed. If you suspect an overdose, contact your Poison Control Center. Treatment includes stopping the drug and checking kidney function.
How your body processes Tobramycin
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Tobramycin does not cross membranes easily, so inhaled doses stay mostly in the airways. Only a small amount reaches the blood. It is not metabolized and is cleared mainly by the kidneys. Half-life in the blood is about 2 to 3 hours.
How to store Tobramycin
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stored under refrigeration at 2°C to 8°C (36°F to 46°F). refrigerator, or if refrigeration is unavailable, tobramycin inhalation solution, USP pouches (opened or unopened) may be stored at room temperature for up to 28 days.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Tobramycin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Tobramycin — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How do I use the inhaled form?
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What side effects are normal?
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When should I call my doctor?
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Can I take it with my other medicines?
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Is it safe in pregnancy?
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Is Tobramycin available over the counter?
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When was Tobramycin first available?
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Who makes Tobramycin?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Tobramycin on HelloPharmacist
Tobramycin forms and strengths (how it comes)
Tobramycin is available in 6 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Tobramycin inactive ingredients by manufacturer.
Injection
How this form is used
- Tobramycin injection treats serious bacterial infections including septicemia, lower respiratory tract infections, meningitis, intra-abdominal infections, skin, bone and skin structure infections, and complicated urinary tract infections.
- Tobramycin injection may be given into a vein or muscle.
- Tobramycin injection dosing is based on body weight and kidney function and is set by the prescriber.
Eye drops
How this form is used
- Tobramycin Ophthalmic Solution treats external eye infections caused by susceptible bacteria.
- Tobramycin Ophthalmic Solution is dosed as drops into the affected eye, more often in severe infections, then reduced before stopping.
Inhalation solution (nebulizer)
How this form is used
- Tobi and Kitabis Pak are used to manage cystic fibrosis with Pseudomonas aeruginosa in people 6 and older.
- Bethkis is used to manage cystic fibrosis with Pseudomonas aeruginosa.
- Tobi and Kitabis Pak are inhaled twice daily in 28 days on, 28 days off cycles using a PARI LC PLUS nebulizer.
- Bethkis is for oral inhalation only, twice daily in 28 days on, 28 days off cycles.
- Bethkis doses should be about 12 hours apart and not less than 6 hours apart.
Inhaler
How this form is used
- TOBI Podhaler is used to manage cystic fibrosis in patients with Pseudomonas aeruginosa.
- TOBI Podhaler capsules are inhaled with the Podhaler device and never swallowed.
Eye ointment
How this form is used
- Tobrex ointment treats external eye infections and the structures around the eye caused by susceptible bacteria.
- Tobrex ointment is applied as a small ribbon into the lower lid pocket. Do not let the tube tip touch your eye.
- Tobrex ointment is used 2 or 3 times daily for mild to moderate disease, and more often in severe infections.
Capsule
How this form is used
- TOBI Podhaler is used to manage cystic fibrosis in patients with Pseudomonas aeruginosa.
- TOBI Podhaler capsules must not be swallowed. Use them only with the Podhaler device.
- TOBI Podhaler is inhaled twice daily for 28 days, in alternating on and off periods.
- With TOBI Podhaler, doses should be about 12 hours apart and never less than 6 hours apart.
Tobramycin on the U.S. market: products, makers and brands
How Tobramycin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
45 companies list 66 Tobramycin product records with the FDA, mostly as injection, eye drops, inhalation solution (nebulizer); the earliest marketing or approval year on record is 1975. Brand names on the directory include Bethkis, Tobi, Kitabis and 6 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (16) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Tobramycin is used (Medicaid data)
A general measure of how commonly Tobramycin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Tobramycin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Tobramycin prescribed? Of the 1,601 medications we measure, Tobramycin ranks #410 by Medicaid prescriptions — more than 74% of them.
Utilization by Tobramycin product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
tobramycin 3 MG/ML Ophthalmic Solution Most dispensed
Summed across the 5 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313415
tobramycin 60 MG/ML Inhalation Solution
Summed across the 9 of 35 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 348719
tobramycin 40 MG/ML Injectable Solution
Summed across the 11 of 37 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 597823
tobramycin 75 MG/ML Inhalation Solution
Summed across the 6 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1314763
tobramycin 0.003 MG/MG Ophthalmic Ointment
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313414
tobramycin 10 MG/ML Injectable Solution
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313416
Other Tobramycin products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 60 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tobramycin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 34 of 201 listed Tobramycin NDCs with Medicaid activity.
Compare Tobramycin products
A representative set of FDA-listed product records for Tobramycin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| 3 mg/mL | Ophthalmic | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Asclemed USA, Inc. × 2 listings | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Bausch & Lomb Incorporated | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Belcher Pharmaceuticals, LLC | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | DirectRX | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Gland Pharma Limited | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Jvet Pharmaceuticals Llc | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | NuCare Pharmaceuticals,Inc. × 2 listings | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Preferred Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Proficient Rx LP × 4 listings | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Remedyrepack Inc. | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Sandoz Inc | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Somerset Therapeutics, LLC | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | Sportpharm LLC × 2 listings | ANDA | View NDC → |
| 3 mg/mL | Ophthalmic | St. Mary's Medical Park Pharmacy | ANDA | View NDC → |
| 💊Eye ointment | ||||
| 3 mg/g | Ophthalmic | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 💊Inhalation solution (nebulizer) | ||||
| 300 mg/5 mL | Respiratory (inhalation) | American Health Packaging | ANDA | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | Ascend Laboratories, LLC | ANDA | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | Aurobindo Pharma Limited | ANDA | View NDC → |
| 300 mg/4 mL | Respiratory (inhalation) | Chiesi USA, Inc. | NDA | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | Genericus, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 300 mg/4 mL | Respiratory (inhalation) | Lifestar Pharma LLC | ANDA | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | Lifestar Pharma LLC | ANDA | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 300 mg/4 mL | Respiratory (inhalation) | NorthStar RxLLC | ANDA | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | NorthStar RxLLC | ANDA | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | Pari Respiratory Equipment, Inc. | NDA | View NDC → |
| 300 mg/4 mL | Respiratory (inhalation) | Prasco, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | Ritedose Pharmaceuticals, LLC | ANDA | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 300 mg/5 mL | Oral, Respiratory (inhalation) | Viatris Specialty LLC | NDA | View NDC → |
| 💊Inhaler | ||||
| 300 mg/5 mL | Respiratory (inhalation) | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | Micro Labs Limited | ANDA | View NDC → |
| 300 mg/5 mL | Respiratory (inhalation) | NorthStar RxLLC | ANDA | View NDC → |
| 28 mg | Oral, Respiratory (inhalation) | Viatris Specialty LLC | NDA | View NDC → |
| 💊Injection | ||||
| 40 mg/mL | Intramuscular, Intravenous | Baxter Healthcare Corporation × 2 listings | ANDA | View NDC → |
| 1.2 g/30 mL | Intravenous | Eugia US LLC | ANDA | View NDC → |
| 1.2 g/30 mL | Intravenous | Fosun Pharma USA Inc | ANDA | View NDC → |
| 10 mg/mL | Intramuscular, Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 40 mg/mL | Intramuscular, Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 1200 mg/30 mL | Intravenous | Fresenius Kabi USA, LLC | NDA | View NDC → |
| 10 mg/mL | Intramuscular, Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 40 mg/mL | Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 40 mg/mL | Intramuscular, Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 1.2 g/30 mL | Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 40 mg/mL | Intramuscular, Intravenous | Hospira, Inc. | ANDA | View NDC → |
| 40 mg/mL | Intramuscular, Intravenous | Mylan Institutional LLC × 2 listings | ANDA | View NDC → |
| 1.2 g/30 mL | Intravenous | Northstar Rx LLC | ANDA | View NDC → |
| 1200 mg/30 mL | Intravenous | Slate Run Pharmaceuticals, LLC | ANDA | View NDC → |
| 1.2 g/30 mL | Intravenous | XGen Pharmaceuticals DJB, Inc. | ANDA | View NDC → |
| 1.2 g/30 mL | Intravenous | Xiromed LLC | ANDA | View NDC → |
Showing 66 of 66 products — FDA National Drug Code Directory. See every product, package size and price: browse all 66 Tobramycin NDCs →
Tobramycin side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tobramycin — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Tobramycin are death, pneumonia, infective pulmonary exacerbation of cystic fibrosis; about 75% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tobramycin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Tobramycin FDA approval history
How Tobramycin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Tobramycin was first approved by the FDA in 1975 (Brand: NEBCIN · Lilly); the first generic version was approved in 1976. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Tobramycin recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 2 Tobramycin recalls since July 2021. One of them is still ongoing and is listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05 Lots: Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024 FDA record D-1086-2023 →
- Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520,… Lots: Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025. FDA record D-0385-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 10627 5 dose forms · 7 strengths
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Dose form (SCDF) Inhalation Powder RxCUI 2108575No current FDA listingClinical drug / strength (SCD) 28 MGRxCUI 1374569 -
Dose form (SCDF) Inhalation Solution RxCUI 2108548In current FDA listings -
Dose form (SCDF) Injectable Solution RxCUI 374147In current FDA listings -
Dose form (SCDF) Ophthalmic Ointment RxCUI 378998In current FDA listingsClinical drug / strength (SCD) 0.003 MG/MGRxCUI 313414 -
Dose form (SCDF) Ophthalmic Solution RxCUI 377400In current FDA listingsClinical drug / strength (SCD) 3 MG/MLRxCUI 313415
Look up RxCUI 10627 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Tobramycin supply and shortage status
Whether Tobramycin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Tobramycin is not in shortage right now; the FDA has 1 past shortage record for it.
✅No current shortage of Tobramycin on recordRead the full Tobramycin shortage page — affected NDCs, other makers, and what to do →
Source: openFDA, from the FDA Drug Shortages database.
💵 What Tobramycin costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Solution · Respiratory (inhalation) | 300 mg/5 mL | $1.08 per mL | NDC details & price history |
| Solution · Ophthalmic | 3 mg/mL | $1.11 per mL | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Tobramycin brand names
Tobramycin is sold under 9 brand names in the FDA directory — Bethkis, Tobi, Kitabis, Tobrex and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Tobramycin: manufacturers and labelers
45 companies list Tobramycin products with the FDA. By number of product records, the largest are Gland Pharma Limited, NorthStar RxLLC, Proficient Rx LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 21 more on the FDA NDC directory.
Tobramycin drug class (RxNorm)
Tobramycin belongs to the Aminoglycoside Antibacterial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Tobramycin page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mylan Specialty L.P. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →