Vancomycin Hydrochloride
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSIONRx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Approved
Approval ID
a7e7d990-1d74-459b-ac07-d1c3e13b3204
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2019
Manufacturers
FDA
Fresenius Kabi, LLC
DUNS: 608775388
Products 1
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 Code63323-314
Application NumberANDA204125
Product Classification
M
Marketing Category
C73584
G
Generic Name
Vancomycin Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 1, 2017
FDA Product Classification
INGREDIENTS (1)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 10 g in 100 mL
Code: 71WO621TJD
Classification: ACTIM