Vancomycin hydrochloride
These highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE FOR INJECTION. VANCOMYCIN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 1958
Approved
Approval ID
9aa42538-c84e-4886-8d3d-a7dfded5120f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 5, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
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 Code55150-471
Application NumberANDA217401
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 5, 2023
FDA Product Classification
INGREDIENTS (1)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 1.25 g in 25 mL
Code: 71WO621TJD
Classification: ACTIM
Vancomycin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-472
Application NumberANDA217401
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 5, 2023
FDA Product Classification
INGREDIENTS (1)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 1.5 g in 30 mL
Code: 71WO621TJD
Classification: ACTIM