fomepizole
Fomepizole Injection Sterile Rx only
Approved
Approval ID
a31d0148-2729-49de-b666-f24b0dfd2401
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 11, 2020
Manufacturers
FDA
American Regent, Inc.
DUNS: 002033710
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fomepizole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-0710
Application NumberANDA078368
Product Classification
M
Marketing Category
C73584
G
Generic Name
fomepizole
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 11, 2020
FDA Product Classification
INGREDIENTS (1)
FOMEPIZOLEActive
Quantity: 1 g in 1 mL
Code: 83LCM6L2BY
Classification: ACTIB