NDC product

fomepizole

NDC 0517-0710 · American Regent, Inc.

Key facts

Product NDC 0517-0710
Proprietary name fomepizole
Nonproprietary name fomepizole
Substances FOMEPIZOLE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler American Regent, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA078368
Pharmacologic classes Antidote [EPC]
Marketing start Jul 16, 2018
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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