Vancomycin Hydrochloride

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

Company

DUNS: 608775388

Effective Date

August 14, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Vancomycin(750 mg in 15 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

840771732

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

NDC Product Code

63323-203

Application Number

ANDA062663

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

August 14, 2023

Ingredients

Code: 71WO621TJDClass: ACTIMQuantity: 750 mg in 15 mL