NDC product

Augtyro

NDC 0003-4040 · E.R. Squibb & Sons, L.L.C.

Key facts

Product NDC 0003-4040
Proprietary name Augtyro
Nonproprietary name repotrectinib
Substances REPOTRECTINIB
Dosage form CAPSULE
Route ORAL
Labeler E.R. Squibb & Sons, L.L.C.
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA218213
Pharmacologic classes Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase A Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase B Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase C Inhibitors [MoA]
Marketing start Dec 5, 2023
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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