NDC 43598-605

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 Dr. Reddy. The primary component is Tobramycin.

• Product ID: 43598-605_150f3b83-980a-2af7-72bb-7fa1510d03a7
• NDC: 43598-605
• Product Type: Human Prescription Drug
• Proprietary Name: Tobramycin Inhalation Solution
• Generic Name: Tobramycin Inhalation Solution
• Dosage Form: Inhalant
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2019-05-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207080
• Labeler Name: Dr. Reddy
• Substance Name: TOBRAMYCIN
• Active Ingredient Strength: 300 mg/5mL
• Pharm Classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 43598-605-56

14 POUCH in 1 CARTON (43598-605-56) > 4 AMPULE in 1 POUCH (43598-605-04) > 5 mL in 1 AMPULE

• Marketing Start Date: 2019-05-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43598-605-56 [43598060556]

Tobramycin Inhalation Solution INHALANT

• Marketing Category: ANDA
• Application Number: ANDA207080
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-05-14

NDC 43598-605-04 [43598060504]

Tobramycin Inhalation Solution INHALANT

• Marketing Category: ANDA
• Application Number: ANDA207080
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-14

Drug Details

Active Ingredients

Ingredient	Strength
TOBRAMYCIN	300 mg/5mL

OpenFDA Data

• SPL SET ID: e5bbf589-d066-c89a-c40f-cbeb6f98c5b5
• Manufacturer:
  • Dr. Reddys Laboratories Inc.
• UNII:
  • VZ8RRZ51VK
• RxNorm Concept Unique ID - RxCUI:
  • 348719

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
16714-119	Tobramycin Inhalation Solution	Tobramycin Inhalation Solution
43598-605	Tobramycin Inhalation Solution	Tobramycin Inhalation Solution
65302-063	Tobramycin Inhalation Solution	Tobramycin