Gentamicin

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 608775388

Effective Date

December 20, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Gentamicin(10 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Fresenius Kabi USA, LLC

DUNS Number

023648251

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

NDC Product Code

63323-173

Application Number

ANDA062366

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

September 2, 2021

Ingredients

Code: 8X7386QRLVClass: ACTIMQuantity: 10 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SULFURIC ACIDInactive

Code: O40UQP6WCFClass: IACT