Tobramycin Inhalation Solution, 300 mg/5 mL

Tobramycin Inhalation Solution by

Drug Labeling and Warnings

Tobramycin Inhalation Solution by is a Prescription medication manufactured, distributed, or labeled by The Ritedose Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOBRAMYCIN INHALATION SOLUTION- tobramycin solution 
The Ritedose Corporation

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Tobramycin Inhalation Solution, 300 mg/5 mL

NDC: 17478-345-05

Tobramycin Inhalation Solution, USP

300 mg/5 mL Ampules

Preservative Free

Attention Pharmacist: Dispense with accompanying Patient Information Leaflet,

Store in Refrigerator

56 Single-dose Ampules

(28-Day Supply)

Tobramycin Inhalation Solution, 300 mg/5 mL 30 Count Carton

TOBRAMYCIN INHALATION SOLUTION 
tobramycin solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 65302-063
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOBRAMYCIN (UNII: VZ8RRZ51VK) (TOBRAMYCIN - UNII:VZ8RRZ51VK)	TOBRAMYCIN	300 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
SULFURIC ACID (UNII: O40UQP6WCF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65302-063-04	14 in 1 CARTON	05/29/2014
1		4 in 1 POUCH
1		5 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA201422	05/29/2014

Labeler - The Ritedose Corporation (837769546)

Establishment
Name	Address	ID/FEI	Business Operations
The Ritedose Corporation		837769546	analysis(65302-063) , manufacture(65302-063) , pack(65302-063) , label(65302-063)

Revised: 12/2022

Document Id: f05e4685-c086-90e3-e053-2995a90a5cd8

34391-3

Set id: f05e4685-c085-90e3-e053-2995a90a5cd8

Version: 1

Effective Time: 20221221