NDC product

nilotinib

NDC 13668-711 · Torrent Pharmaceuticals Limited

Key facts

Product NDC 13668-711
Proprietary name nilotinib
Nonproprietary name nilotinib
Substances NILOTINIB HYDROCHLORIDE MONOHYDRATE
Dosage form CAPSULE
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA218532
Pharmacologic classes Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC] and 2 more
Marketing start Dec 16, 2025
Listing certified through Dec 31, 2027

At a glance

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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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