FDA-filed SPL labeling · retrieved through openFDA

Tobramycin

Tobramycin is an antibiotic used to manage cystic fibrosis lung infections, treat serious bacterial infections by injection, and treat bacterial eye infections.

Brand names BethkisTobiKitabisTobrexTobramycin Inhalation Solution +4 more
Drug class Aminoglycoside Antibacterial
Rx Forms 7 Routes Ophthalmic · Respiratory (inhalation) · Intravenous · Intramuscular, Intravenous +4
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 32 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 →

At a glance
Linked label effectiveNov 1, 2019
Clinical labels in scope 32
AvailabilityRx
Earliest approval/marketing year 1975
FDA-listed product records 186
Boxed warningNone found in compared labels
How we combine label and product data →
Other forms & routes:
Tobramycin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Tobramycin is a targeted antibiotic used in specific situations — inhaled to control lung infections in cystic fibrosis, applied to treat bacterial eye infections, or given by injection for serious infections throughout the body. It is effective but requires monitoring for ear and kidney side effects, especially with injected forms. Always take it exactly as prescribed and report any ringing in the ears, hearing changes, or decreased urination to your doctor right away.

📖 Tobramycin: Patient Information Guide

A plain-language walkthrough of Tobramycin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Tobramycin is an antibiotic available in several forms for different types of bacterial infections.

  • Cystic fibrosis lung infections: Inhaled tobramycin products — including TOBI, Bethkis, Kitabis Pak, tobramycin inhalation solution, and TOBI Podhaler — are used to manage Pseudomonas aeruginosa lung infections in adults and children 6 years and older with cystic fibrosis.
  • Bacterial eye infections: Tobramycin ophthalmic solution and Tobrex eye drops treat external bacterial infections of the eye and surrounding area. Tobrex ophthalmic ointment is also used for this purpose.
  • Serious systemic bacterial infections (injection only): Tobramycin injection treats bloodstream infections (septicemia), lower respiratory tract infections, meningitis, intra-abdominal infections (including peritonitis), skin and bone infections, and complicated urinary tract infections caused by susceptible bacteria.
⚙️How it works

Tobramycin is an aminoglycoside antibiotic that kills bacteria by disrupting their ability to make proteins. When protein production breaks down, the bacterial cell membrane becomes unstable, the cell envelope degrades, and the bacteria die. It is particularly active against gram-negative bacteria, including Pseudomonas aeruginosa, the main lung pathogen targeted in cystic fibrosis treatment. Tobramycin is bactericidal — meaning it actively kills bacteria rather than just slowing their growth.

Bacteria can develop resistance to tobramycin, most commonly in cystic fibrosis patients, through reduced ability to absorb the drug or through enzymes that modify it. Some cross-resistance with other aminoglycosides is possible, though it varies.

💊How it's taken

How and how often tobramycin is taken depends entirely on the form prescribed — there is no one-size-fits-all schedule.

  • Inhaled solutions (nebulizer): Taken twice daily by inhalation, roughly 12 hours apart (never less than 6 hours apart), in repeating cycles of 28 days on treatment followed by 28 days off. Always inhaled through a nebulizer — never swallowed.
  • TOBI Podhaler (capsule for inhalation): Four capsules inhaled twice daily using the Podhaler device, in the same 28-days-on/28-days-off cycle. The capsules must never be swallowed.
  • Eye drops and ointment: Applied directly to the affected eye several times a day, with frequency depending on how severe the infection is; follow your prescriber's guidance.
  • Injection: Given by a healthcare professional intravenously or intramuscularly; the timing and number of doses per day are set by your care team based on your condition and kidney function.
🤒Side effects — in detail

The most common side effects reported with inhaled tobramycin products include:

  • Cough or productive cough (coughing up mucus)
  • Shortness of breath
  • Hoarse or changed voice (dysphonia)
  • Sore throat or mouth pain
  • Fever
  • Headache
  • Coughing up blood (hemoptysis)
  • Taste disturbance (dysgeusia), particularly in younger patients using TOBI Podhaler

Serious reactions to watch for include sudden airway tightening (bronchospasm) after inhalation, ringing in the ears or hearing loss, signs of kidney problems such as decreased urination, and unusual muscle weakness. Contact your doctor right away if any of these occur.

⚠️Warnings & precautions
  • Hearing and ear damage (ototoxicity): Ringing in the ears (tinnitus), dizziness, and hearing loss have been reported with tobramycin. People with certain inherited gene variants (MT-RNR1) face a higher risk of permanent hearing loss, even at normal drug levels. Tell your doctor about any personal or family history of aminoglycoside-related hearing loss.
  • Kidney damage (nephrotoxicity): Aminoglycosides as a class can harm the kidneys. Those with existing kidney problems or taking other kidney-affecting drugs need close monitoring of kidney function and tobramycin levels.
  • Bronchospasm: Sudden airway tightening can occur when inhaling tobramycin. It should be treated promptly if it happens.
  • Neuromuscular effects: Tobramycin can worsen muscle weakness in people with conditions like myasthenia gravis or Parkinson's disease, and may cause breathing paralysis — particularly if neuromuscular-blocking drugs are also being used.
  • Fetal harm: Aminoglycosides cross the placenta and can cause permanent deafness in a baby exposed before birth. Pregnant women should discuss the risks carefully with their doctor.
🔀What it interacts with

Tobramycin can interact with several types of drugs, increasing the risk of serious side effects:

  • Other nephrotoxic, ototoxic, or neurotoxic drugs: Using tobramycin at the same time as other drugs that can harm the kidneys, ears, or nervous system should be avoided — the combined effect can be more dangerous than either drug alone.
  • Certain diuretics (water pills) — ethacrynic acid, furosemide, urea, intravenous mannitol: These can increase tobramycin levels in the body and raise the risk of toxicity; do not combine with inhaled tobramycin solutions.
  • Injectable aminoglycoside antibiotics: If you are also receiving tobramycin or another aminoglycoside by injection, your doctor will need to monitor you closely for signs of toxicity, since the total drug exposure increases.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not take tobramycin if you have had a serious allergic reaction to tobramycin or any other aminoglycoside antibiotic — this is a contraindication.
  • Tell your doctor if you have kidney disease or reduced kidney function — tobramycin is cleared primarily through the kidneys, and impaired kidneys increase the risk of side effects.
  • Tell your doctor if you have any hearing problems or vestibular (balance) issues — tobramycin can worsen these.
  • Inform your doctor if you or a close female relative experienced hearing loss from aminoglycoside use, or if you have a known mitochondrial DNA variant — alternative treatments may be safer.
  • Tell your doctor if you have myasthenia gravis, Parkinson's disease, or any condition affecting muscle or nerve function.
  • Inhaled tobramycin products have not been established as safe or effective in children under 6 years of age.
  • Older adults are more likely to have reduced kidney function and may need kidney monitoring during treatment.
  • Tell your doctor if you are pregnant or breastfeeding — aminoglycosides can potentially harm a developing baby, and tobramycin may pass into breast milk and affect the breastfed infant's gut bacteria.
🚑If you take too much

Signs of too much tobramycin — most relevant with injected forms — can include dizziness, ringing in the ears, vertigo, hearing loss, kidney problems, and difficulty breathing due to neuromuscular effects. If an overdose is suspected, stop the medication and contact your regional Poison Control Center or emergency services immediately. Hemodialysis (a kidney-filtering procedure) may be used to help remove tobramycin from the body if needed.

📡Pharmacodynamics — effects in the body

Tobramycin kills bacteria by disrupting their protein-making machinery, which leads to breakdown of the cell membrane and ultimately cell death. It is bactericidal — meaning it kills bacteria outright — at concentrations at or above the minimum amount needed to stop bacterial growth. It has activity against a broad range of gram-negative bacteria, with particular effectiveness against Pseudomonas aeruginosa. When inhaled, it reaches very high concentrations in the airway secretions (sputum) of the lungs while keeping systemic (whole-body) levels low.

🔬Pharmacokinetics — how your body processes it

When tobramycin is inhaled, it stays mostly in the lungs and does not easily cross into the bloodstream — it is a polar molecule that does not readily pass through cell membranes. Systemic absorption from inhaled forms is low, but what is absorbed is eliminated unchanged by the kidneys through a process called glomerular filtration. The half-life (time for half the drug to leave the body) after inhalation is approximately 3 to 4.4 hours. Tobramycin is not broken down (metabolized) by the body; it is excreted unchanged, mostly in urine. Any portion not absorbed after inhalation is likely cleared out with expectorated sputum. Protein binding in the blood is negligible.

📦How to store it

Store at 20° to 25°C (68° to 77°F) . Protect from excessive heat.

📄 Written from Tobramycin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

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 tobramycin actually used for?
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 to manage a Pseudomonas aeruginosa lung infection in cystic fibrosis. If you have eye drops or ointment, it's treating a bacterial eye infection. And if it's being given as an injection in a hospital or clinic setting, it's treating a more serious bacterial infection somewhere in the body.
Why do I have to take the inhaled form for 28 days and then stop for 28 days?
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 reduce the chance of the bacteria becoming resistant to the antibiotic. It's important to stick to the cycle even if you feel better during the 'off' weeks.
I use the TOBI Podhaler — can I just swallow the capsule instead of inhaling it?
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 device. Swallowing the capsule would mean the antibiotic never reaches your lungs, so it wouldn't treat the infection at all.
What side effects should I actually call my doctor about?
The ones that matter most are ringing in your ears, any change in your hearing, dizziness, or balance problems — these can be early signs of ear or hearing damage from tobramycin. Also call if you notice you're urinating much less than usual, which could signal kidney strain. And if you feel sudden chest tightness or serious trouble breathing right after inhaling the medication, get help right away. Everyday things like cough, mild hoarseness, or a sore throat are common with the inhaled forms and less urgent, but still worth mentioning at your next appointment.
Is it safe to use tobramycin if I'm pregnant or trying to get pregnant?
This is a conversation you need to have with your doctor before using it. Aminoglycoside antibiotics — the class tobramycin belongs to — can cross the placenta and have been linked to hearing damage in babies exposed before birth. The risk with inhaled tobramycin is likely lower because not much of it enters the bloodstream from the lungs, but it's not zero. Your doctor will weigh the risks of the infection against the potential risk to the baby and help you make the right decision.
Are there any medications I should avoid while taking tobramycin?
Yes, a few important ones. You should avoid taking other drugs that can also harm the kidneys or ears at the same time — your pharmacist or doctor can review your full medication list. If you're using the inhaled solution, don't combine it with certain diuretics (water pills) like furosemide or ethacrynic acid, since those can raise tobramycin levels to a potentially harmful range. And if you're also getting tobramycin or another aminoglycoside antibiotic by injection, your care team needs to know so they can monitor you carefully.
Is Tobramycin available over the counter?
Tobramycin is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Tobramycin first available?
Tobramycin has been available in the United States since at least 1975, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Tobramycin?
Tobramycin is supplied by 67 manufacturers listed in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Gland Pharma Limited, A-S Medication Solutions.

💬 Answers drafted from Tobramycin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Tobramycin comes

Tobramycin is available in 7 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.

Eye drops

In the eye
Brands Tobrex
How this form is used
What it may be used for
  • Tobramycin ophthalmic solution treats external bacterial infections of the eye and surrounding area caused by susceptible bacteria
Important instructions
  • For mild to moderate infections, instill 1 or 2 drops into the affected eye(s) every 4 hours
  • For severe infections, instill 2 drops hourly until improvement, then reduce frequency as directed by your doctor
Available strengths 1 strength
62 FDA-listed product records

Injection

By injection · Into a muscle · Into a vein
How this form is used
What it may be used for
  • Tobramycin injection treats serious bloodstream infections (septicemia) in newborns, children, and adults
  • Tobramycin injection treats serious lower respiratory tract infections, meningitis, intra-abdominal infections including peritonitis, and skin and bone infections
  • Tobramycin injection treats complicated and recurrent urinary tract infections caused by susceptible bacteria
Important instructions
  • Tobramycin injection is given by a healthcare provider into a vein (intravenously) or into a muscle (intramuscularly)
  • Dosing frequency and duration are determined by your healthcare provider based on the type and severity of infection and your kidney function
Available strengths 4 strengths
48 FDA-listed product records

Inhalation solution (nebulizer)

By mouth · Inhaled
Brands Bethkis Kitabis Pak Tobi Tobramycin Inhalation
How this form is used
What it may be used for
  • TOBI is used to manage cystic fibrosis in adults and children 6 years and older with Pseudomonas aeruginosa lung infection
  • Bethkis is used to manage cystic fibrosis patients with Pseudomonas aeruginosa
  • Kitabis Pak is used to manage cystic fibrosis in adults and children 6 years and older with Pseudomonas aeruginosa
  • Tobramycin inhalation solution products are used to manage cystic fibrosis in adults and children 6 years and older with Pseudomonas aeruginosa
Important instructions
  • TOBI and Kitabis Pak are inhaled twice daily, with doses taken as close to 12 hours apart as possible and never less than 6 hours apart
  • Bethkis and tobramycin inhalation solution are taken as one full ampule twice daily by inhalation, in cycles of 28 days on followed by 28 days off
  • Kitabis Pak is co-packaged with a PARI LC PLUS Reusable Nebulizer; use it with the provided nebulizer and a DeVilbiss Pulmo-Aide compressor
  • Never swallow the inhalation solution — it is for oral inhalation through a nebulizer device only
Available strengths 2 strengths
43 FDA-listed product records

Inhaler

By mouth · Inhaled
Brands TOBI Podhaler Tobramycin Inhalation Solution
Available strengths 2 strengths
11 FDA-listed product records

Eye ointment

In the eye
Brands Tobrex
How this form is used
What it may be used for
  • Tobrex ophthalmic ointment treats external bacterial infections of the eye and surrounding area caused by susceptible bacteria
Important instructions
  • For mild to moderate infections, apply a half-inch ribbon of Tobrex ointment into the affected eye(s) 2 or 3 times per day
  • For severe infections, apply a half-inch ribbon every 3 to 4 hours until improvement, then reduce frequency before stopping
  • Tilt your head back, gently pull down your lower eyelid to form a small pocket, and place the ointment there — do not let the tube tip touch your eye
Available strengths 1 strength
4 FDA-listed product records

Capsule

By mouth
Brands TOBI Podhaler
How this form is used
What it may be used for
  • TOBI Podhaler is used to manage cystic fibrosis in adults and children 6 years and older with Pseudomonas aeruginosa lung infection
Important instructions
  • TOBI Podhaler capsules must NOT be swallowed — they are for inhalation only using the Podhaler device
  • Inhale the contents of four capsules twice daily, with doses taken as close to 12 hours apart as possible and never less than 6 hours apart
  • TOBI Podhaler is taken in cycles of 28 days on, followed by 28 days off
  • Dosage is not adjusted by weight
Available strengths 1 strength
1 FDA-listed product record

Oral solution

By mouth
Brands Tobi
Available strengths 1 strength
1 FDA-listed product record

📊 Tobramycin across the U.S. market

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.

7
Dose forms
67
Manufacturers
10
Brand names
186
FDA-listed product records
1975
First marketed

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.

Fresenius Kabi USA, LLC7%
Gland Pharma Limited5%
A-S Medication Solutions4%
NorthStar RxLLC4%
Teva Pharmaceuticals USA, Inc.4%
Mylan Institutional LLC4%
Other makers72%

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

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.

179,203
Medicaid prescriptions filled (Q1–Q4 2025)
$35.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tobramycin prescribed? Of the 1,596 medications we measure, Tobramycin ranks #410 by Medicaid prescriptions — more than 74% of them.

Where Tobramycin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

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.

The 3 mg/mL ophthalmic solution is the most-dispensed Tobramycin product — about 88% of these Medicaid prescriptions.

tobramycin 3 MG/ML Ophthalmic Solution Most dispensed

158,221 Medicaid prescriptions (Q1–Q4 2025) 88% of Tobramycin prescriptions shown $1.7M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

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

10,235 Medicaid prescriptions (Q1–Q4 2025) 6% of Tobramycin prescriptions shown $13.7M gross reimbursement (before rebates) ≈ $1,335 per prescription (gross)

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

5,987 Medicaid prescriptions (Q1–Q4 2025) 3% of Tobramycin prescriptions shown $971,001 gross reimbursement (before rebates) ≈ $162 per prescription (gross)

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

2,575 Medicaid prescriptions (Q1–Q4 2025) 1% of Tobramycin prescriptions shown $12.8M gross reimbursement (before rebates) ≈ $4,982 per prescription (gross)

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

1,645 Medicaid prescriptions (Q1–Q4 2025) <1% of Tobramycin prescriptions shown $473,967 gross reimbursement (before rebates) ≈ $288 per prescription (gross)

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

41 Medicaid prescriptions (Q2–Q3 2025) <1% of Tobramycin prescriptions shown $39 gross reimbursement (before rebates) ≈ $0.96 per prescription (gross)

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)

499 Medicaid prescriptions (Q1–Q4 2025) <1% of Tobramycin prescriptions shown $5.6M gross reimbursement (before rebates) ≈ $11,271 per prescription (gross)

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.)

Showing 186 of 186 products — FDA National Drug Code Directory. See every product, package size and price: browse all 186 Tobramycin NDCs →

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.

Ingredient (IN) Tobramycin RxCUI 10627 5 dose forms · 7 strengths
  1. Dose form (SCDF) Inhalation Powder RxCUI 2108575 No current FDA listing
    Clinical drug / strength (SCD) 28 MG RxCUI 1374569
  2. Dose form (SCDF) Inhalation Solution RxCUI 2108548 In current FDA listings
    Clinical drug / strength (SCD) 60 MG/ML RxCUI 348719 75 MG/ML RxCUI 1314763
  3. Dose form (SCDF) Injectable Solution RxCUI 374147 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 313416 40 MG/ML RxCUI 597823
  4. Dose form (SCDF) Ophthalmic Ointment RxCUI 378998 In current FDA listings
    Clinical drug / strength (SCD) 0.003 MG/MG RxCUI 313414
  5. Dose form (SCDF) Ophthalmic Solution RxCUI 377400 In current FDA listings
    Clinical drug / strength (SCD) 3 MG/ML RxCUI 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.

🏷️ Sold under these brand names

Bethkis Tobi Kitabis Tobrex Tobramycin Inhalation Solution TOBI Podhaler Kitabis Pak Tobramycin Inhalation Tobramycin Inhalation Solution Pak

🏭 Manufacturers & labelers

Fresenius Kabi USA, LLC 10 Gland Pharma Limited 8 A-S Medication Solutions 6 NorthStar RxLLC 6 Teva Pharmaceuticals USA, Inc. 6 Mylan Institutional LLC 6 Baxter Healthcare Corporation 6 RPK Pharmaceuticals, Inc. 6 Preferred Pharmaceuticals Inc. 6 NuCare Pharmaceuticals,Inc. 5 Mylan Specialty L.P. 5 Lifestar Pharma LLC 5 Fosun Pharma USA Inc 5 Novartis Pharmaceuticals Corporation 4 Remedyrepack Inc. 4 Proficient Rx LP 4 DirectRX 3 Viatris Specialty LLC 3 Xiromed LLC 3 Genericus, Inc. 3 St. Mary's Medical Park Pharmacy 3 Pari Respiratory Equipment, Inc. 3 Xellia Pharmaceuticals ApS 3 Somerset Therapeutics, LLC 3

…and 16 more on the FDA NDC directory.

RxNorm drug class

Tobramycin belongs to the Aminoglycoside Antibacterial class.

Pharmacologic class Aminoglycoside Antibacterial
Drug family (ATC) Other aminoglycosides, Antibiotics

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.

🔬 Where this comes from

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 1, 2019
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tobramycin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Tobramycin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
32
NDC products indexed
186
Distinct labelers/manufacturers represented
67
Linked representative label
Proficient Rx LP
Linked label effective
Nov 1, 2019
Composite sections available
16
Linked SPL Set ID
ac497300-eb1e-4021-b504-89f19e1eb0f3
Linked SPL Document ID
f1b5aa19-119f-4d5a-aa8d-8f3778a48753
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 32 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Proficient Rx LP is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.