Vancomycin
These highlights do not include all the information needed to use VANCOMYCIN INJECTION safely and effectively. See full prescribing information for VANCOMYCIN INJECTION. VANCOMYCIN injection, for intravenous use or oral use Initial U.S. Approval: 1958
Approved
Approval ID
5105259a-c16e-4875-a920-50fefc92b822
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 10, 2021
Manufacturers
FDA
Xellia Pharmaceuticals USA LLC
DUNS: 116768762
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vancomycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70594-040
Application NumberNDA213895
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vancomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 10, 2021
FDA Product Classification
INGREDIENTS (1)
VANCOMYCINActive
Quantity: 5 g in 100 mL
Code: 6Q205EH1VU
Classification: ACTIB