NDC 0078-0494

TOBI

Tobramycin

TOBI is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Tobramycin.

• Product ID: 0078-0494_cb71e4dc-f6a7-455f-b72c-78cb8a4d3fee
• NDC: 0078-0494
• Product Type: Human Prescription Drug
• Proprietary Name: TOBI
• Generic Name: Tobramycin
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 1997-12-22
• Marketing Category: NDA / NDA
• Application Number: NDA050753
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: TOBRAMYCIN
• Active Ingredient Strength: 300 mg/5mL
• Pharm Classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0078-0494-71

56 POUCH in 1 CARTON (0078-0494-71) > 4 AMPULE in 1 POUCH (0078-0494-91) > 5 mL in 1 AMPULE (0078-0494-61)

• Marketing Start Date: 1997-12-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0494-91 [00078049491]

TOBI SOLUTION

• Marketing Category: NDA
• Application Number: NDA050753
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-07-02

NDC 0078-0494-61 [00078049461]

TOBI SOLUTION

• Marketing Category: NDA
• Application Number: NDA050753
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1997-12-22

NDC 0078-0494-71 [00078049471]

TOBI SOLUTION

• Marketing Category: NDA
• Application Number: NDA050753
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1997-12-22

Drug Details

Active Ingredients

Ingredient	Strength
TOBRAMYCIN	300 mg/5mL

OpenFDA Data

• SPL SET ID: 94f9e516-6bf6-4e30-8dde-8833c25c2560
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • VZ8RRZ51VK
• RxNorm Concept Unique ID - RxCUI:
  • 213194
  • 348719

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0078-0494	TOBI	Tobramycin
10122-820	BETHKIS	tobramycin
0078-0630	TOBI Podhaler	Tobramycin
0093-3750	Tobramycin	Tobramycin
0093-4085	Tobramycin	Tobramycin
0404-7196	Tobramycin	Tobramycin
0409-3578	TOBRAMYCIN	TOBRAMYCIN
0703-9402	Tobramycin	Tobramycin
0781-7171	Tobramycin	Tobramycin
10544-883	Tobramycin	Tobramycin
13985-604	Tobramycin	Tobramycin
13985-743	Tobramycin	Tobramycin
17478-290	Tobramycin	Tobramycin
17478-340	Tobramycin	Tobramycin
0065-0643	Tobrex	tobramycin
0065-0644	TOBREX	tobramycin
0078-0813	TOBREX	tobramycin