Fomepizole
Fomepizole Injection, 1.5 grams per 1.5 mL (1 gram per mL)(For Intravenous Infusion Only)Sterile
Approved
Approval ID
1dea37fd-ec17-416e-b28e-980a87d49e1a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2023
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 080579617
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 Code25021-829
Application NumberANDA216791
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fomepizole
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (1)
FomepizoleActive
Quantity: 1.5 g in 1.5 mL
Code: 83LCM6L2BY
Classification: ACTIB