TOBRAMYCIN INHALATION SOLUTION- tobramycin solution 
The Ritedose Corporation

----------

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-30count-carton

TOBRAMYCIN INHALATION SOLUTION 
tobramycin solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65302-063
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOBRAMYCIN (UNII: VZ8RRZ51VK) (TOBRAMYCIN - UNII:VZ8RRZ51VK) TOBRAMYCIN300 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
SULFURIC ACID (UNII: O40UQP6WCF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65302-063-0414 in 1 CARTON05/29/2014
14 in 1 POUCH
15 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20142205/29/2014
Labeler - The Ritedose Corporation (837769546)
Establishment
NameAddressID/FEIBusiness Operations
The Ritedose Corporation837769546analysis(65302-063) , manufacture(65302-063) , pack(65302-063) , label(65302-063)

Revised: 12/2022
Document Id: f05e4685-c086-90e3-e053-2995a90a5cd8
Set id: f05e4685-c085-90e3-e053-2995a90a5cd8
Version: 1
Effective Time: 20221221
 
The Ritedose Corporation