NDC 16714-119

Tobramycin Inhalation Solution

Tobramycin Inhalation Solution

Tobramycin Inhalation Solution is a Respiratory (inhalation) Inhalant in the Human Prescription Drug category. It is labeled and distributed by Northstar Rxllc. The primary component is Tobramycin.

Product ID16714-119_0581501c-9a3c-0bac-107c-9f546a30657e
NDC16714-119
Product TypeHuman Prescription Drug
Proprietary NameTobramycin Inhalation Solution
Generic NameTobramycin Inhalation Solution
Dosage FormInhalant
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2020-05-21
Marketing CategoryANDA / ANDA
Application NumberANDA207080
Labeler NameNorthStar RxLLC
Substance NameTOBRAMYCIN
Active Ingredient Strength300 mg/5mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 16714-119-03

14 POUCH in 1 CARTON (16714-119-03) > 4 AMPULE in 1 POUCH > 5 mL in 1 AMPULE (16714-119-02)
Marketing Start Date2020-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-119-03 [16714011903]

Tobramycin Inhalation Solution INHALANT
Marketing CategoryANDA
Application NumberANDA207080
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-21

NDC 16714-119-02 [16714011902]

Tobramycin Inhalation Solution INHALANT
Marketing CategoryANDA
Application NumberANDA207080
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-21

Drug Details

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

NDCBrand NameGeneric Name
16714-119Tobramycin Inhalation SolutionTobramycin Inhalation Solution
43598-605Tobramycin Inhalation SolutionTobramycin Inhalation Solution
65302-063Tobramycin Inhalation SolutionTobramycin

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