Tobramycin Solution
Product Images NDC 72603-430

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Tobramycin (NDC 72603-430). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rxllc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Structure (0d806a34 E83d 4ce4 9da2 1630c49790a8 01)

Chemical structure of the active ingredient tobramycin, showing its molecular composition with multiple rings and amino and hydroxyl functional groups.*

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Figure 1: Relative Change From Baseline In Fev 1% Predicted (0d806a34 E83d 4ce4 9da2 1630c49790a8 02)

A line graph showing average relative change in FEV1 percent predicted over 24 weeks for two studies comparing Tobramycin Inhalation Solution (300 mg/5 mL) with placebo. Tobramycin groups show increased FEV1, peaking early and maintaining improvement, while placebo groups remain near baseline with slight fluctuations.*

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Figure 2: Absolute Change From Baseline In Log 10 Cfus (0d806a34 E83d 4ce4 9da2 1630c49790a8 03)

Line graph depicting the average change of Log10 CFUs over weeks in two studies comparing placebo and Tobramycin Inhalation Solution. The x-axis represents weeks, and the y-axis shows average change in Log10 CFUs, with data points indicating bacterial count changes during on-drug periods for study 1 and study 2 groups.*

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Instructions For Use Figure A (0d806a34 E83d 4ce4 9da2 1630c49790a8 04)

An instructional illustration showing components of a respiratory inhalation solution setup, labeled as Air Compressor, Nebulizer Cup, Inspiratory Valve Cap, Ampule, Mouthpiece, Clean paper or cloth towels, and Tubing. The ampule is labeled as Tobramycin Inhalation Solution, USP 300 mg/5 mL.*

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Instructions For Use Figure B (0d806a34 E83d 4ce4 9da2 1630c49790a8 05)

An instructional illustration showing two hands holding single-use plastic ampules labeled Tobramycin Inhalation Solution USP 300 mg/5 mL. The image depicts the motion of twisting or snapping the tops off the ampules for use.*

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Instructions For Use Figure C (0d806a34 E83d 4ce4 9da2 1630c49790a8 06)

Label of TOBRAMYCIN inhalation solution USP 300 mg/5 mL in a single-dose vial. The label shows the product name, strength, and dosage form. It also includes designated spaces for the lot number and expiration date. The labeler is NorthStar RxLLC.*

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Instructions For Use Figure D (0d806a34 E83d 4ce4 9da2 1630c49790a8 07)

Instructional diagram showing assembly of a nebulizer device for respiratory inhalation. The labeled parts include the Nebulizer Top being attached to the Nebulizer Cup, with additional components such as the Mouthpiece, Tubing, and Inspiratory Valve Cap displayed to illustrate setup for inhalation therapy.*

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Instructions For Use Figure E (0d806a34 E83d 4ce4 9da2 1630c49790a8 08)

An instructional illustration showing the assembly of a nebulizer device for inhalation solution. It depicts a hand inserting the Nebulizer Insert into the Nebulizer Cup, with an arrow indicating the direction of insertion and labels identifying the Top, Nebulizer Insert, and Nebulizer Cup components.*

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Instructions For Use Figure F (0d806a34 E83d 4ce4 9da2 1630c49790a8 09)

An instructional illustration showing a nebulizer cup and its top component placed on a clean paper or cloth towel. The parts are labeled to identify the nebulizer cup and its top piece clearly. The image highlights keeping these parts clean before assembly or use.*

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Instructions For Use Figure G (0d806a34 E83d 4ce4 9da2 1630c49790a8 10)

An instructional illustration showing a hand placing a small round tablet into a device labeled 'Pulmo Aide,' which appears to be a medical or respiratory device with a flip-down panel and a side switch, likely related to inhalation therapy.*

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Instructions For Use Figure H (0d806a34 E83d 4ce4 9da2 1630c49790a8 11)

An instructional illustration showing a hand plugging a two-prong electrical plug into a standard dual electrical outlet. An arrow points toward the outlet indicating the direction to insert the plug. This image likely relates to safe or proper electrical connection instructions.*

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Instructions For Use Figure I (0d806a34 E83d 4ce4 9da2 1630c49790a8 12)

An instructional illustration showing a person holding and peeling the bottom tab of a Tobramycin Inhalation Solution, USP 300 mg/5 mL vial. The image highlights the vial label and the action of removing the tab from the bottom of the vial.*

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Instructions For Use Figure J (0d806a34 E83d 4ce4 9da2 1630c49790a8 13)

An instructional illustration depicting a hand holding a solution ampule above a nebulizer cup, with a drop falling from the ampule into the cup, demonstrating the proper method for adding solution to the device.*

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Instructions For Use Figure K (0d806a34 E83d 4ce4 9da2 1630c49790a8 14)

An instructional diagram illustrating the assembly of a nebulizer device. It shows the nebulizer top with a stem and semi-circle, aligned above the nebulizer cup which includes a nebulizer outlet. An arrow indicates the top should be rotated to secure it onto the cup.*

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Instructions For Use Figure L (0d806a34 E83d 4ce4 9da2 1630c49790a8 15)

Illustration showing assembly of a respiratory inhalation device labeled for Tobramycin solution. It depicts the nebulizer cup on the right side with a labeled nebulizer outlet, and the mouthpiece positioned on the left, indicating how it connects to the nebulizer outlet.*

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Instructions For Use Figure M (0d806a34 E83d 4ce4 9da2 1630c49790a8 16)

An illustration showing the inspiratory valve cap being placed onto a respiratory inhalation device component, likely part of a tobramycin inhalation solution delivery system. The valve cap is depicted above the main mouthpiece unit with arrows indicating placement.*

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Instructions For Use Figure N (0d806a34 E83d 4ce4 9da2 1630c49790a8 17)

An instructional diagram showing the assembly of a nebulizer device. The image highlights the air intake on the nebulizer's main body and illustrates connecting the mouthpiece to the air supply tube with directional arrows.*

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Instructions For Use Figure O (0d806a34 E83d 4ce4 9da2 1630c49790a8 18)

An instructional illustration showing a hand operating a lever or switch on a Pulmo Aide device, a medical device used for respiratory inhalation therapy. The image focuses on the hand and control area of the Pulmo Aide unit.*

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Instructions For Use Figure P (0d806a34 E83d 4ce4 9da2 1630c49790a8 19)

An instructional illustration depicting the assembly and use of a nebulizer device, showing mist being emitted from the mouthpiece. The device includes a mouthpiece, medication cup, and tubing connection for inhalation of a respiratory solution.*

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Instructions For Use Figure Q (0d806a34 E83d 4ce4 9da2 1630c49790a8 20)

An instructional illustration showing a person using a respiratory inhalation solution device with a nose clip attached. The image highlights the proper placement of the device at the mouth and the nose clip for inhalation administration.*

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Pouch Label (0d806a34 E83d 4ce4 9da2 1630c49790a8 21)

TOBRAMYCIN Inhalation Solution, USP 300 mg/5 mL is a sterile respiratory inhalation solution for nebulizer use. The label states it contains no preservatives, should be stored refrigerated, and includes 4 single-dose 5 mL ampules per pouch. Labeler is NorthStar RxLLC.*

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Carton (0d806a34 E83d 4ce4 9da2 1630c49790a8 22)

Label for Tobramycin Inhalation Solution, USP 300 mg/5 mL by NorthStar RxLLC. The label indicates it is for respiratory inhalation use via nebulizer, preservative-free, sterile, with storage instructions to keep refrigerated. The packaging contains 56 single-dose 5 mL ampules (14 pouches of 4 ampules each). Manufacturer details include NorthStar RxLLC and Mankind Pharma Limited.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.