"0003-4160-60" National Drug Code (NDC)

NDC Code	0003-4160-60
Package Description	60 CAPSULE in 1 BOTTLE (0003-4160-60)
Product NDC	0003-4160
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Augtyro
Non-Proprietary Name	Repotrectinib
Dosage Form	CAPSULE
Usage	ORAL
Start Marketing Date	20241101
Marketing Category Name	NDA
Application Number	NDA218213
Manufacturer	E.R. Squibb & Sons, L.L.C.
Substance Name	REPOTRECTINIB
Strength	160
Strength Unit	mg/1
Pharmacy 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]