NDC 0078-0630

TOBI Podhaler

Tobramycin

TOBI Podhaler is a Oral; Respiratory (inhalation) Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Tobramycin.

Product ID0078-0630_21fcb4b7-b59c-4c0c-b87e-377f0ad5753b
NDC0078-0630
Product TypeHuman Prescription Drug
Proprietary NameTOBI Podhaler
Generic NameTobramycin
Dosage FormCapsule
Route of AdministrationORAL; RESPIRATORY (INHALATION)
Marketing Start Date2013-03-22
Marketing CategoryNDA / NDA
Application NumberNDA201688
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameTOBRAMYCIN
Active Ingredient Strength28 mg/1
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0630-35

224 PACKAGE in 1 BOX, UNIT-DOSE (0078-0630-35) > 56 BLISTER PACK in 1 PACKAGE (0078-0630-56) > 4 CAPSULE in 1 BLISTER PACK (0078-0630-11)
Marketing Start Date2013-03-22
Marketing End Date2022-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0630-20 [00078063020]

TOBI Podhaler CAPSULE
Marketing CategoryNDA
Application NumberNDA201688
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-22

NDC 0078-0630-35 [00078063035]

TOBI Podhaler CAPSULE
Marketing CategoryNDA
Application NumberNDA201688
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-03-22

NDC 0078-0630-56 [00078063056]

TOBI Podhaler CAPSULE
Marketing CategoryNDA
Application NumberNDA201688
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-03-22

NDC 0078-0630-11 [00078063011]

TOBI Podhaler CAPSULE
Marketing CategoryNDA
Application NumberNDA201688
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-03-22

NDC 0078-0630-19 [00078063019]

TOBI Podhaler CAPSULE
Marketing CategoryNDA
Application NumberNDA201688
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-03-22

Drug Details

Active Ingredients

IngredientStrength
TOBRAMYCIN28 mg/1

OpenFDA Data

SPL SET ID:625a4499-4e46-4f5a-8d0c-d104f520d97e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1661560
  • 1661567
  • 1661559
  • 1374569
  • 1374570
  • 1661466
  • 1374573
  • 1374574
  • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]
    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

    NDC Crossover Matching brand name "TOBI Podhaler" or generic name "Tobramycin"

    NDCBrand NameGeneric Name
    0078-0630TOBI PodhalerTobramycin
    49502-346TOBI PodhalerTOBI Podhaler
    10122-820BETHKIStobramycin
    0078-0494TOBITobramycin
    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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