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Vancomycin Hydrochloride

Vancomycin Hydrochloride for Injection, USP (For Intravenous Use)

Approved
Approval ID

8403695c-3614-490b-9797-6c5ebcdeef9b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 12, 2023

Manufacturers
FDA

Xellia Pharmaceuticals USA LLC

DUNS: 116768762

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 Code70594-122
Application NumberANDA205694
Product Classification
M
Marketing Category
C73584
G
Generic Name
vancomycin hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 12, 2023
FDA Product Classification

INGREDIENTS (1)

VANCOMYCIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 71WO621TJD
Classification: ACTIM

vancomycin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70594-123
Application NumberANDA205694
Product Classification
M
Marketing Category
C73584
G
Generic Name
vancomycin hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 12, 2023
FDA Product Classification

INGREDIENTS (1)

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

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