FDA.reportPublic FDA data

RETEVMO

Product NDC
0002-2980
11-digit product format
000022980
Labeler code
0002
Product ID
0002-2980_94e137ac-9f6b-4904-8999-3e55603a2407
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
selpercatinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Eli Lilly and Company
Application
NDA213246
Marketing category
NDA
Marketing start
2020-05-08
Substance
SELPERCATINIB
Active strength
80 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

Additional Listing Data#

Finished product
Yes
Brand name base
RETEVMO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELPERCATINIB80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCEGM9YBNGD
Rxcui2370164, 2370170, 2370172, 2370174, 2679805, 2679808, 2679810, 2679812, 2679813, 2679814, 2679815, 2679816

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
481381ff-cc0d-406c-b479-0f9e6be2c48aProduct name120201001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-2980-26RETEVMO120 in 1 BOTTLECAPSULE12022
0002-2980-60RETEVMO60 in 1 BOTTLECAPSULE6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-2980-26EA - Each0002-2980d9f002b1-95eb-4e7e-8017-349797f06a7c12020-06-05
0002-2980-60EA - Each0002-298004cee046-0899-48f8-b893-0397a12284ad12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-2980RETEVMO (SELPERCATINIB) CAPSULE RETEVMO (SELPERCATINIB) TABLET, COATED [ELI LILLY AND COMPANY]18Current NDC, Legacy NDC, 2 package rows20250103_7fa848ba-a59c-4144-9f52-64d090f4d828.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2679808Retevmo 120 MG Oral TabletPSN7fa848ba-a59c-4144-9f52-64d090f4d82822
2679812Retevmo 160 MG Oral TabletPSN7fa848ba-a59c-4144-9f52-64d090f4d82822
2370170Retevmo 40 MG Oral CapsulePSN7fa848ba-a59c-4144-9f52-64d090f4d82822
2679814Retevmo 40 MG Oral TabletPSN7fa848ba-a59c-4144-9f52-64d090f4d82822
2370174Retevmo 80 MG Oral CapsulePSN7fa848ba-a59c-4144-9f52-64d090f4d82822
2679816Retevmo 80 MG Oral TabletPSN7fa848ba-a59c-4144-9f52-64d090f4d82822
2679805selpercatinib 120 MG Oral TabletPSN7fa848ba-a59c-4144-9f52-64d090f4d82822
2679810selpercatinib 160 MG Oral TabletPSN7fa848ba-a59c-4144-9f52-64d090f4d82822
2370164selpercatinib 40 MG Oral CapsulePSN7fa848ba-a59c-4144-9f52-64d090f4d82822
2679813selpercatinib 40 MG Oral TabletPSN7fa848ba-a59c-4144-9f52-64d090f4d82822
2370172selpercatinib 80 MG Oral CapsulePSN7fa848ba-a59c-4144-9f52-64d090f4d82822
2679815selpercatinib 80 MG Oral TabletPSN7fa848ba-a59c-4144-9f52-64d090f4d82822
2679808selpercatinib 120 MG Oral Tablet [Retevmo]SBD7fa848ba-a59c-4144-9f52-64d090f4d82822
2679812selpercatinib 160 MG Oral Tablet [Retevmo]SBD7fa848ba-a59c-4144-9f52-64d090f4d82822
2370170selpercatinib 40 MG Oral Capsule [Retevmo]SBD7fa848ba-a59c-4144-9f52-64d090f4d82822
2679814selpercatinib 40 MG Oral Tablet [Retevmo]SBD7fa848ba-a59c-4144-9f52-64d090f4d82822
2370174selpercatinib 80 MG Oral Capsule [Retevmo]SBD7fa848ba-a59c-4144-9f52-64d090f4d82822
2679816selpercatinib 80 MG Oral Tablet [Retevmo]SBD7fa848ba-a59c-4144-9f52-64d090f4d82822
2679805selpercatinib 120 MG Oral TabletSCD7fa848ba-a59c-4144-9f52-64d090f4d82822
2679810selpercatinib 160 MG Oral TabletSCD7fa848ba-a59c-4144-9f52-64d090f4d82822
2370164selpercatinib 40 MG Oral CapsuleSCD7fa848ba-a59c-4144-9f52-64d090f4d82822
2679813selpercatinib 40 MG Oral TabletSCD7fa848ba-a59c-4144-9f52-64d090f4d82822
2370172selpercatinib 80 MG Oral CapsuleSCD7fa848ba-a59c-4144-9f52-64d090f4d82822
2679815selpercatinib 80 MG Oral TabletSCD7fa848ba-a59c-4144-9f52-64d090f4d82822
2679808Retevmo 120 MG Oral TabletSY7fa848ba-a59c-4144-9f52-64d090f4d82822
2679812Retevmo 160 MG Oral TabletSY7fa848ba-a59c-4144-9f52-64d090f4d82822
2370170Retevmo 40 MG Oral CapsuleSY7fa848ba-a59c-4144-9f52-64d090f4d82822
2679814Retevmo 40 MG Oral TabletSY7fa848ba-a59c-4144-9f52-64d090f4d82822
2370174Retevmo 80 MG Oral CapsuleSY7fa848ba-a59c-4144-9f52-64d090f4d82822
2679816Retevmo 80 MG Oral TabletSY7fa848ba-a59c-4144-9f52-64d090f4d82822
2679805selpercatinib 120 MG Oral TabletSY7fa848ba-a59c-4144-9f52-64d090f4d82822
2679810selpercatinib 160 MG Oral TabletSY7fa848ba-a59c-4144-9f52-64d090f4d82822
2679813selpercatinib 40 MG Oral TabletSY7fa848ba-a59c-4144-9f52-64d090f4d82822
2679815selpercatinib 80 MG Oral TabletSY7fa848ba-a59c-4144-9f52-64d090f4d82822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-2980-2600002298026120 CAPSULE in 1 BOTTLE (0002-2980-26) 120 capsule2020-05-080000-00-00NoNoCurrent
0002-2980-600000229806060 CAPSULE in 1 BOTTLE (0002-2980-60) 60 capsule2020-05-080000-00-00NoNoCurrent