MedPath

Vancomycin Hydrochloride

Vancomycin Hydrochloride for Injection, USP (For Intravenous Use) Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Approved
Approval ID

00946db3-d6c5-4534-a870-1ec6e63eda43

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 23, 2022

Manufacturers
FDA

Gland Pharma Limited

DUNS: 918601238

Products 2

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

Vancomycin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68083-143
Application NumberANDA205694
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 23, 2022
FDA Product Classification

INGREDIENTS (1)

VANCOMYCIN HYDROCHLORIDEActive
Quantity: 500 mg in 10 mL
Code: 71WO621TJD
Classification: ACTIM

Vancomycin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68083-144
Application NumberANDA205694
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 23, 2022
FDA Product Classification

INGREDIENTS (1)

VANCOMYCIN HYDROCHLORIDEActive
Quantity: 1 g in 20 mL
Code: 71WO621TJD
Classification: ACTIM

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Vancomycin Hydrochloride - FDA Drug Approval Details