MedPath

Vancomycin Hydrochloride

Approved
Approval ID

d3147f2d-1a72-4923-874b-8fdee2be625e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 30, 2021

Manufacturers
FDA

Fresenius Kabi USA, 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 Code63323-295
Application NumberANDA062663
Product Classification
M
Marketing Category
C73584
G
Generic Name
VANCOMYCIN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 9, 2021
FDA Product Classification

INGREDIENTS (1)

VANCOMYCIN HYDROCHLORIDEActive
Quantity: 5 g in 100 mL
Code: 71WO621TJD
Classification: ACTIM

VANCOMYCIN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-314
Application NumberANDA062663
Product Classification
M
Marketing Category
C73584
G
Generic Name
VANCOMYCIN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 9, 2021
FDA Product Classification

INGREDIENTS (1)

VANCOMYCIN HYDROCHLORIDEActive
Quantity: 10 g in 100 mL
Code: 71WO621TJD
Classification: ACTIM

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