Tobramycin Inhalation Solution (300 mg/5 mL)

Drug Labeling and Warnings

Drug Details [pdf]

TOBRAMYCIN- tobramycin solution 
Holopack Verpackungstechnik GmbH

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Tobramycin Inhalation Solution (300 mg/5 mL)

Tobramycin

Tobramycin Inhalation solution, for oral inhalation use

PRINCIPAL DISPLAY PANEL - SHIPPER LABEL

1 carton = 504 ampoules

Tobramycin Inhalation Solution (300 mg/5 mL)

Lot: UP115

Exp: 12-2019

Caution: For manufacturing, processing, or repacking.

Store at 2°-8°C (36°-46°F). Do not freeze.

9 boxes of 14 pouches of 4 ampoules of 5 mL

Carton # 0180

Made in Germany

Dr. Reddy's Laboratories SA

Elisabethenanlage 11,CH

Basel, CH, Switzerland - 4051

Tobramycin Inhalation

TOBRAMYCIN 
tobramycin solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60940-025
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOBRAMYCIN (UNII: VZ8RRZ51VK) (TOBRAMYCIN - UNII:VZ8RRZ51VK) TOBRAMYCIN60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SULFURIC ACID (UNII: O40UQP6WCF)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 60940-025-01504 in 1 CARTON09/07/2018
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
ANDAANDA20708009/07/2018
Labeler - Holopack Verpackungstechnik GmbH (313222457)
Establishment
NameAddressID/FEIBusiness Operations
Holopack Verpackungstechnik GmbH343390324manufacture(60940-025)

Revised: 10/2018
Document Id: 1c2cc9ca-0204-4afe-ac08-6961c6b40ff8
Set id: 6c6fa857-4b6f-482b-afd8-4bedd729e6bb
Version: 1
Effective Time: 20181016