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Prescription medicine · generic available

Tobramycin

Brand names: Tobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler, Bethkis, Tobrex, Kitabis Pak

Also listed by the FDA as: tobramycin · tobramycin sulfate

Drug class: Aminoglycoside Antibacterial

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

Some labelsBoxed warning
To be discontinuedFDA shortage list
2Recalls (FDA reports)
46Companies
1981First FDA approval on file

Quick answers

What is Tobramycin used for?
The FDA-approved label (Tobramycin Inhalation Solution Pak, Genericus, Inc., December 13, 2024) says: “TOBRAMYCIN INHALATION SOLUTION PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Tobramycin have a boxed warning?
The label we quote has no boxed warning, but 15 of 60 FDA labels for this medicine do. Check the label of your own product.
Is there a shortage of Tobramycin?
The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated July 17, 2026). Ask your pharmacist about alternatives.
Has Tobramycin been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started February 22, 2024 (Class II). A recall usually concerns specific lots, not every product.
Who makes Tobramycin?
46 companies list prescription products of Tobramycin in the FDA NDC Directory, including Gland Pharma Limited, Proficient Rx LP and Fresenius Kabi USA, LLC.

What Tobramycin is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

TOBRAMYCIN INHALATION SOLUTION PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. …

— FDA label: Tobramycin Inhalation Solution Pak, Genericus, Inc., effective December 13, 2024. Read the full label on DailyMed →

The FDA has 60 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

15 of 60 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsSolution · Solution/ drops · Injection · Injection, powder, lyophilized, for solution · Inhalant · Injection, powder, for solution · Injection, solution · Capsule · Ointment
RouteOphthalmic · Respiratory (inhalation) · Intravenous · Intramuscular · Oral
Prescription products66 in the FDA NDC Directory
Brand namesTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler, Bethkis, Tobrex, Kitabis Pak

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Tobramycin, by strength and form
Strength and formGeneric or brandPharmacies pay
tobramycin 0.3%
ointment		 Brand: Tobrex $84.33 per gram
tobramycin 3 mg/mL
solution		 Generic $1.10 per mL
tobramycin 3 mg/mL
solution/ drops		 Generic $1.10 per mL
tobramycin 300 mg/5 mL
inhalant		 Generic $1.05 per mL
tobramycin 300 mg/5 mL
solution		 Generic $1.05 per mL
tobramycin sulfate 40 mg/mL
injection		 Generic $0.9279 per mL
tobramycin sulfate 40 mg/mL
injection, solution		 Generic $0.9279 per mL

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA050555
TOBREX		 NovartisNovember 25, 1981 16, latest May 14, 2021
2021: Labeling · 2020: Labeling · 2015: Manufacturing (CMC)
NDA050753
TOBI		 ViatrisDecember 22, 1997 15, latest February 10, 2023
2023: Labeling · 2018: Labeling · 2018: Labeling
NDA050789
TOBRAMYCIN SULFATE		 Fresenius Kabi USAJuly 13, 2004 6, latest February 10, 2023
2023: Labeling · 2021: Labeling · 2020: Labeling
NDA201688
TOBI PODHALER		 ViatrisMarch 22, 2013 11, latest February 10, 2023
2023: Labeling · 2020: Labeling · 2017: Manufacturing (CMC)
NDA201820
BETHKIS		 ChiesiOctober 12, 2012 4, latest February 10, 2023
2023: Labeling · 2019: Labeling · 2017: Labeling
NDA205433
KITABIS PAK		 Pulmoflow IncDecember 2, 2014 4, latest April 10, 2023
2023: Labeling · 2023: Labeling · 2019: Labeling

Generic approvals (27)

Shortage status

To be discontinued · updated July 17, 2026 · first posted July 17, 2026

ProductTobramycin Sulfate, Injection, 80 mg/2 mL (40 mg/mL); 2 mL Multiple Dose Glass Fliptop Vial (NDC 0409-3578-01)
CompanyHospira, Inc., a Pfizer Company

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. February 22, 2024 · Class II · Terminated · D-0385-2024

    Failed Stability Specification: Water determination was found not complying with specification.

    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, Carton NDC 55150-470 — Eugia US LLC

  2. July 27, 2023 · Class III · Ongoing · D-1086-2023

    Failed Impurities/Degradation Specifications

    Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05 — ALEMBIC PHARMACEUTICALS, INC.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)213194, 313415, 313416, 348719, 597823, 1314763, 1314768, 1374569, 1374570, 1374573 … (+6)
SPL set ID of the quoted labeldad13445-f591-4829-96f9-1598ba03dff8
FDA labels (SPL)60
FDA applicationsNDA050555, NDA050753, NDA050789, NDA201688, NDA201820, NDA205433, 27 ANDA
Active ingredients (FDA)TOBRAMYCIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Tobramycin Inhalation Solution Pak, Genericus, Inc., effective December 13, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers