NDC product

TIBSOVO

NDC 72694-617 · Servier Pharmaceutical LLC

Key facts

Product NDC 72694-617
Proprietary name TIBSOVO
Nonproprietary name ivosidenib
Substances IVOSIDENIB
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Servier Pharmaceutical LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA211192
Pharmacologic classes Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Isocitrate Dehydrogenase 1 Inhibitor [EPC], Isocitrate Dehydrogenase 1 Inhibitors [MoA]
Marketing start Oct 19, 2021
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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