NDC 49502-346

TOBI Podhaler

Tobramycin

TOBI Podhaler is a Oral; Respiratory (inhalation) Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Specialty L.p.. The primary component is Tobramycin.

Product ID49502-346_0a289436-17b1-413b-8343-c3b029f39990
NDC49502-346
Product TypeHuman Prescription Drug
Proprietary NameTOBI Podhaler
Generic NameTobramycin
Dosage FormCapsule
Route of AdministrationORAL; RESPIRATORY (INHALATION)
Marketing Start Date2020-09-24
Marketing CategoryNDA / NDA
Application NumberNDA201688
Labeler NameMylan Specialty L.P.
Substance NameTOBRAMYCIN
Active Ingredient Strength28 mg/1
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 49502-346-24

224 PACKAGE in 1 BOX, UNIT-DOSE (49502-346-24) > 56 BLISTER PACK in 1 PACKAGE > 4 CAPSULE in 1 BLISTER PACK
Marketing Start Date2020-09-24
NDC Exclude FlagN
Sample Package?N

Drug Details

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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