NDC product

Gomekli

NDC 82448-134 · SpringWorks Therapeutics, Inc.

Key facts

Product NDC 82448-134
Proprietary name Gomekli
Nonproprietary name mirdametinib
Substances MIRDAMETINIB
Dosage form TABLET, FOR SUSPENSION
Route ORAL
Labeler SpringWorks Therapeutics, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA219379
Pharmacologic classes Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]
Marketing start Feb 11, 2025
Listing certified through Dec 31, 2027

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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