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Vancomycin Hydrochloride

Vancomycin Hydrochloride for Injection, USP For Intravenous Use Rx only

Approved
Approval ID

78984781-3c0b-4b73-ba85-10d60ecb2a28

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 7, 2023

Manufacturers
FDA

Eugia US LLC

DUNS: 968961354

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 Code55150-203
Application NumberANDA205780
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 7, 2023
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 Code55150-204
Application NumberANDA205780
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 7, 2023
FDA Product Classification

INGREDIENTS (1)

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

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Vancomycin Hydrochloride - FDA Drug Approval Details