RETEVMO

Product NDC
0002-6120
11-digit product format
000026120
Labeler code
0002
Product ID
0002-6120_94e137ac-9f6b-4904-8999-3e55603a2407
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
selpercatinib
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Eli Lilly and Company
Application
NDA218160
Marketing category
NDA
Marketing start
2024-04-10
Substance
SELPERCATINIB
Active strength
120 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Rearranged during Transfection (RET) Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
CEGM9YBNGDSELPERCATINIB2152628-33-4SELPERCATINIB

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0002-6120-600000261206060 TABLET, COATED in 1 BOTTLE (0002-6120-60) 2024-04-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
RETEVMOEli Lilly and Company | Loxo Oncology, Inc.2025-11-20HUMAN PRESCRIPTION DRUG LABEL22