NDC 24492-850

Kitabis Pak

Tobramycin

Kitabis Pak is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Pari Respiratory Equipment. The primary component is Tobramycin.

Product ID24492-850_1fbb7583-bed5-44ce-a24a-245dd407a74e
NDC24492-850
Product TypeHuman Prescription Drug
Proprietary NameKitabis Pak
Generic NameTobramycin
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2015-02-19
Marketing CategoryNDA / NDA
Application NumberNDA205433
Labeler NamePari Respiratory Equipment
Substance NameTOBRAMYCIN
Active Ingredient Strength300 mg/5mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 24492-850-56

14 POUCH in 1 CARTON (24492-850-56) > 4 AMPULE in 1 POUCH > 5 mL in 1 AMPULE
Marketing Start Date2015-02-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24492-850-56 [24492085056]

Kitabis Pak SOLUTION
Marketing CategoryNDA
Application NumberNDA205433
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-02-19

Drug Details

Active Ingredients

IngredientStrength
TOBRAMYCIN300 mg/5mL

OpenFDA Data

SPL SET ID:da1e5afd-d707-4af1-8935-8195ba6d769f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 348719
  • 1596030
  • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

    NDC Crossover Matching brand name "Kitabis Pak" or generic name "Tobramycin"

    NDCBrand NameGeneric Name
    24492-850Kitabis PakKitabis 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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