NDC 70644-899

Tobramycin Inhalation Solution Pak

Tobramycin

Tobramycin Inhalation Solution Pak is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Genericus, Inc.. The primary component is Tobramycin.

Product ID70644-899_29d69d6a-ab70-4222-b06e-2a26a2ca1e85
NDC70644-899
Product TypeHuman Prescription Drug
Proprietary NameTobramycin Inhalation Solution Pak
Generic NameTobramycin
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2016-07-11
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA205433
Labeler NameGenericus, Inc.
Substance NameTOBRAMYCIN
Active Ingredient Strength300 mg/5mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70644-899-99

14 POUCH in 1 CARTON (70644-899-99) > 4 AMPULE in 1 POUCH > 5 mL in 1 AMPULE
Marketing Start Date2016-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70644-899-99 [70644089999]

Tobramycin Inhalation Solution Pak SOLUTION
Marketing CategoryNDA authorized generic
Application NumberNDA205433
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-07-11

Drug Details

Active Ingredients

IngredientStrength
TOBRAMYCIN300 mg/5mL

OpenFDA Data

SPL SET ID:dad13445-f591-4829-96f9-1598ba03dff8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 348719

    • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

    NDC Crossover Matching brand name "Tobramycin Inhalation Solution Pak" or generic name "Tobramycin"

    NDCBrand NameGeneric Name
    70644-899Tobramycin Inhalation Solution PakTobramycin Inhalation Solution Pak
    10122-820BETHKIStobramycin
    0078-0494TOBITobramycin
    0078-0630TOBI PodhalerTobramycin
    0093-3750TobramycinTobramycin
    0093-4085TobramycinTobramycin
    0404-7196TobramycinTobramycin
    0409-3578TOBRAMYCINTOBRAMYCIN
    0703-9402TobramycinTobramycin
    0781-7171TobramycinTobramycin
    10544-883TobramycinTobramycin
    13985-604TobramycinTobramycin
    13985-743TobramycinTobramycin
    17478-290TobramycinTobramycin
    17478-340TobramycinTobramycin
    0065-0643Tobrextobramycin
    0065-0644TOBREXtobramycin
    0078-0813TOBREXtobramycin
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