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Vancomycin Hydrochloride

Vancomycin Hydrochloride for Injection USP For Intravenous Use 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

418c3c6a-d08d-448c-89c9-54e558c1ce16

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 2, 2022

Manufacturers
FDA

Fresenius Kabi, LLC

DUNS: 608775388

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 Code63323-284
Application NumberANDA204107
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 11, 2019
FDA Product Classification

INGREDIENTS (1)

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

Vancomycin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-221
Application NumberANDA204107
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 11, 2019
FDA Product Classification

INGREDIENTS (1)

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

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Vancomycin Hydrochloride - FDA Drug Approval Details