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Tobramycin

Tobramycin for Injection USP PHARMACY BULK PACKAGE —NOT FOR DIRECT INFUSION Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Approved
Approval ID

c4751a4f-c9c1-60c5-e053-2995a90aeba9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 10, 2023

Manufacturers
FDA

Fosun Pharma USA Inc

DUNS: 080920998

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tobramycin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72266-163
Application NumberANDA211189
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tobramycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 10, 2023
FDA Product Classification

INGREDIENTS (1)

TOBRAMYCIN SULFATEActive
Quantity: 1.2 g in 30 mL
Code: HJT0RXD7JK
Classification: ACTIM

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 5/20/2021

HOW SUPPLIED

Tobramycin for injection, USP, is available as:

NDC No.

Fill Volume

72266-163-06

Tobramycin for Injection, USP 1.2 g per vial, in packages of Six in One carton

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

This container closure is not made with natural rubber latex.

Distributed by:
Fosun Pharma USA Inc.

Princeton, NJ 08540

Made in India.

April 2021

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