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Vancomycin Hydrochloride

Approved
Approval ID

afe99d8a-b127-4a95-aed6-66e696630b28

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 30, 2023

Manufacturers
FDA

NorthStar Rx LLC

DUNS: 830546433

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 Code16714-699
Application NumberANDA205779
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 21, 2023
FDA Product Classification

INGREDIENTS (1)

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

Vancomycin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16714-517
Application NumberANDA205779
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 21, 2023
FDA Product Classification

INGREDIENTS (1)

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

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Vancomycin Hydrochloride - FDA Drug Approval Details