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Tobramycin Inhalation Solution

Dosage form: inhalation solution
Drug class: Aminoglycosides, Inhaled anti-infectives

Medically reviewed by Drugs.com. Last updated on Aug 1, 2021.

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

TOBRAMYCIN
tobramycin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60940-027
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM HYDROXIDE
SULFURIC ACID
WATER
Packaging
# Item Code Package Description
1 NDC:60940-027-01 56 POUCH in 1 CARTON
1 7 AMPULE in 1 POUCH
1 5 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212848 08/31/2021
Labeler - Holopack Verpackungstechnik GmbH (313222457)
Establishment
Name Address ID/FEI Operations
Holopack Verpackungstechnik GmbH 343390324 manufacture(60940-027)
Holopack Verpackungstechnik GmbH