Fomepizole
Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL) Sterile Rx only
Approved
Approval ID
7e133194-dacb-446a-a657-2d2430a02373
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 7, 2023
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
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 Code68083-510
Application NumberANDA216791
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fomepizole
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 10, 2023
FDA Product Classification
INGREDIENTS (1)
FOMEPIZOLEActive
Quantity: 1 g in 1 mL
Code: 83LCM6L2BY
Classification: ACTIB