"0003-4040-12" National Drug Code (NDC)

Augtyro 120 CAPSULE in 1 BOTTLE (0003-4040-12)
(E.R. Squibb & Sons, L.L.C.)

NDC Code0003-4040-12
Package Description120 CAPSULE in 1 BOTTLE (0003-4040-12)
Product NDC0003-4040
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAugtyro
Non-Proprietary NameRepotrectinib
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20231205
Marketing Category NameNDA
Application NumberNDA218213
ManufacturerE.R. Squibb & Sons, L.L.C.
Substance NameREPOTRECTINIB
Strength40
Strength Unitmg/1
Pharmacy ClassesCytochrome 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]

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