Tobramycin Inhalation solution, for oral inhalation use

Tobramycin by

Drug Labeling and Warnings

Tobramycin by is a Prescription medication manufactured, distributed, or labeled by Holopack Verpackungstechnik GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOBRAMYCIN- tobramycin solution 
Holopack Verpackungstechnik GmbH

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Tobramycin Inhalation solution, for oral inhalation use

Tobramycin Inhalation solution, for oral inhalation use

Tobramycin Inhalation Solution,

USP 300 mg/5 mL

NDC Code ASCEND: 67877-678-70

NDC Code Holopack: 60940-027-01

Store in a refrigerator at 2° to 8°C (36° to 46°F).

Mfd. By:

Holopack Verpackungstechnik GmbH

Bahnhofstr., 74429 Sulzbach-Laufen

Germany

Holopack Material No.: 011-01568

EXP 06/2024 Lot EXAMPLE02 QTY16

(17) 240630(10)EXAMPLE02(30)16

(01)50367877678707(21)0123456789AB

Holopack

TOBRAMYCIN 
tobramycin solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60940-027
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: 60940-027-0156 in 1 CARTON08/31/2021
17 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
ANDAANDA21284808/31/2021
Labeler - Holopack Verpackungstechnik GmbH (313222457)
Establishment
NameAddressID/FEIBusiness Operations
Holopack Verpackungstechnik GmbH343390324manufacture(60940-027)

Revised: 8/2021
Document Id: ca7de493-36d2-0934-e053-2995a90a95ab
Set id: ca7de493-36d1-0934-e053-2995a90a95ab
Version: 1
Effective Time: 20210826