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Vancomycin Hydrochloride

Vancomycin Hydrochloride for Injection, USP

Approved
Approval ID

cae9e5f3-b89a-4a7f-93f7-9471c74a3559

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 7, 2021

Manufacturers
FDA

Hikma Pharmaceuticals USA Inc.

DUNS: 001230762

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 Code0143-9358
Application NumberANDA204360
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 7, 2021
FDA Product Classification

INGREDIENTS (1)

VANCOMYCIN HYDROCHLORIDEActive
Quantity: 5 g in 1 1
Code: 71WO621TJD
Classification: ACTIM

Vancomycin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0143-9359
Application NumberANDA204360
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 7, 2021
FDA Product Classification

INGREDIENTS (1)

VANCOMYCIN HYDROCHLORIDEActive
Quantity: 10 g in 1 1
Code: 71WO621TJD
Classification: ACTIM

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Vancomycin Hydrochloride - FDA Drug Approval Details