Tobramycin

Basic Information

Product Name

Tobramycin

FDA Product Code

70756-617

Regulatory Information

NDC Product Code

70756-617

Application Number

ANDA216725

Marketing Category

C73584

Effective Date

March 10, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use TOBRAMYCIN INHALATION SOLUTION safely and effectively. See full prescribing information for TOBRAMYCIN INHALATION SOLUTION. TOBRAMYCIN inhalation solution for oral inhalation use Initial U.S. Approval: 1980

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

TOBRAMYCIN

Quantity: 300 mg in 4 mL

Code: VZ8RRZ51VK

Class Code: ACTIB

Inactive Ingredients

SULFURIC ACID

Code: O40UQP6WCF

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

Code: VZ8RRZ51VK

Tobramycin

Basic Information

Regulatory Information

Company Information

Active Ingredients

Inactive Ingredients

SULFURIC ACID

WATER

SODIUM CHLORIDE

SODIUM HYDROXIDE

Active Moieties

TOBRAMYCIN