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FDA Approval

Vancomycin Hydrochloride

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

FDA Approval Summary

Company
Fresenius Kabi USA, LLC
DUNS: 608775388
Effective Date
September 30, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vancomycin(5 g in 100 mL)

Manufacturing Establishments1

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

Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC

840771732

Products2

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

Vancomycin Hydrochloride

Product Details

NDC Product Code
63323-295
Application Number
ANDA062663
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
March 9, 2021
VancomycinActive
Code: 71WO621TJDClass: ACTIMQuantity: 5 g in 100 mL

Vancomycin Hydrochloride

Product Details

NDC Product Code
63323-314
Application Number
ANDA062663
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
March 9, 2021
VancomycinActive
Code: 71WO621TJDClass: ACTIMQuantity: 10 g in 100 mL
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Vancomycin Hydrochloride - FDA Approval | MedPath