OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

RETEVMO

selpercatinib · Tablet, Coated

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
RETEVMO
Generic name
selpercatinib
Dosage form
Tablet, Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Eli Lilly and Company
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
4
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Selpercatinib 120 mg/1 — View
Selpercatinib 160 mg/1 — View
Selpercatinib 40 mg/1 — View
Selpercatinib 80 mg/1 — View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
Route of administration
Oral
Presentations
8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Breast Cancer Resistance Protein Inhibitors [MoA] MoA All 44 members
Cytochrome P450 2C8 Inhibitors [MoA] MoA All 56 members
Cytochrome P450 3A Inhibitors [MoA] MoA All 89 members
Kinase Inhibitor [EPC] EPC All 89 members
Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA] MoA 9 members — no class page
P-Glycoprotein Inhibitors [MoA] MoA All 105 members
Rearranged during Transfection (RET) Inhibitors [MoA] MoA 3 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
218160
Application type
NDA · New Drug Application
Approval date
April 10, 2024
Sponsor
ELI LILLY AND CO
Products on application
6
Submissions recorded
8
Products approved under application 218160.
Product Trade name Form Strength Ingredient Status TE Flags
218160-001 RETEVMO TABLET SELPERCATINIB Prescription — RLD
218160-002 RETEVMO TABLET SELPERCATINIB Prescription — RLD
218160-003 RETEVMO TABLET SELPERCATINIB Prescription — RLD
218160-004 RETEVMO TABLET SELPERCATINIB Prescription — RLD RS
218160-005 RETEVMO CAPSULE SELPERCATINIB Prescription —
218160-006 RETEVMO CAPSULE SELPERCATINIB Prescription —

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
10172851 October 10, 2037 001 No U-3450 May 9, 2024
10137124 October 10, 2037 001 No U-3450 May 9, 2024
10137124 October 10, 2037 001 No U-3949 May 9, 2024
10137124 October 10, 2037 001 No U-3950 May 9, 2024
10137124 October 10, 2037 001 No U-3951 May 9, 2024
10172851 October 10, 2037 001 No U-3949 May 9, 2024
10172851 October 10, 2037 001 No U-3950 May 9, 2024
10172851 October 10, 2037 001 No U-3951 May 9, 2024
10112942 October 10, 2037 001 Yes May 9, 2024
10172851 October 10, 2037 002 No U-3450 May 9, 2024
10137124 October 10, 2037 002 No U-3450 May 9, 2024
10137124 October 10, 2037 002 No U-3949 May 9, 2024
10137124 October 10, 2037 002 No U-3950 May 9, 2024
10137124 October 10, 2037 002 No U-3951 May 9, 2024
10172851 October 10, 2037 002 No U-3949 May 9, 2024
10172851 October 10, 2037 002 No U-3950 May 9, 2024
10172851 October 10, 2037 002 No U-3951 May 9, 2024
10112942 October 10, 2037 002 Yes May 9, 2024
10172851 October 10, 2037 003 No U-3450 May 9, 2024
10137124 October 10, 2037 003 No U-3450 May 9, 2024
10137124 October 10, 2037 003 No U-3949 May 9, 2024
10137124 October 10, 2037 003 No U-3950 May 9, 2024
10137124 October 10, 2037 003 No U-3951 May 9, 2024
10172851 October 10, 2037 003 No U-3949 May 9, 2024
10172851 October 10, 2037 003 No U-3950 May 9, 2024
10172851 October 10, 2037 003 No U-3951 May 9, 2024
10112942 October 10, 2037 003 Yes May 9, 2024
10172851 October 10, 2037 004 No U-3450 May 9, 2024
10137124 October 10, 2037 004 No U-3450 May 9, 2024
10137124 October 10, 2037 004 No U-3949 May 9, 2024
10137124 October 10, 2037 004 No U-3950 May 9, 2024
10137124 October 10, 2037 004 No U-3951 May 9, 2024
10172851 October 10, 2037 004 No U-3949 May 9, 2024
10172851 October 10, 2037 004 No U-3951 May 9, 2024
10172851 October 10, 2037 004 No U-3950 May 9, 2024
10112942 October 10, 2037 004 Yes May 9, 2024
10172851*PED April 10, 2038 001 No —
10137124*PED April 10, 2038 001 No —
10112942*PED April 10, 2038 001 No —
10172851*PED April 10, 2038 002 No —
10137124*PED April 10, 2038 002 No —
10112942*PED April 10, 2038 002 No —
10172851*PED April 10, 2038 003 No —
10137124*PED April 10, 2038 003 No —
10112942*PED April 10, 2038 003 No —
10172851*PED April 10, 2038 004 No —
10137124*PED April 10, 2038 004 No —
10112942*PED April 10, 2038 004 No —
12138250 October 10, 2038 001 No U-3450 December 5, 2024
12138250 October 10, 2038 001 No U-3949 December 5, 2024
12138250 October 10, 2038 001 No U-3951 December 5, 2024
12138250 October 10, 2038 001 No U-3950 December 5, 2024
12138250 October 10, 2038 002 No U-3450 December 5, 2024
12138250 October 10, 2038 002 No U-3951 December 5, 2024
12138250 October 10, 2038 002 No U-3950 December 5, 2024
12138250 October 10, 2038 002 No U-3949 December 5, 2024
12138250 October 10, 2038 003 No U-3450 December 5, 2024
12138250 October 10, 2038 003 No U-3951 December 5, 2024
12138250 October 10, 2038 003 No U-3950 December 5, 2024
12138250 October 10, 2038 003 No U-3949 December 5, 2024
12138250 October 10, 2038 004 No U-3450 December 5, 2024
12138250 October 10, 2038 004 No U-3951 December 5, 2024
12138250 October 10, 2038 004 No U-3950 December 5, 2024
12138250 October 10, 2038 004 No U-3949 December 5, 2024
12138250*PED April 10, 2039 001 No —
12138250*PED April 10, 2039 002 No —
12138250*PED April 10, 2039 003 No —
12138250*PED April 10, 2039 004 No —
Regulatory exclusivity periods.
Code Expires Product
ODE* May 8, 2027 001
ODE* May 8, 2027 001
ODE* May 8, 2027 001
ODE* May 8, 2027 002
ODE* May 8, 2027 002
ODE* May 8, 2027 002
ODE* May 8, 2027 003
ODE* May 8, 2027 003
ODE* May 8, 2027 003
ODE* May 8, 2027 004
ODE* May 8, 2027 004
ODE* May 8, 2027 004
M-311 September 27, 2027 001
M-312 September 27, 2027 001
M-311 September 27, 2027 002
M-312 September 27, 2027 002
M-311 September 27, 2027 003
M-312 September 27, 2027 003
M-311 September 27, 2027 004
M-312 September 27, 2027 004
PED November 8, 2027 001
PED November 8, 2027 001
PED November 8, 2027 001
PED November 8, 2027 002
PED November 8, 2027 002
PED November 8, 2027 002
PED November 8, 2027 003
PED November 8, 2027 003
PED November 8, 2027 003
PED November 8, 2027 004
PED November 8, 2027 004
PED November 8, 2027 004
PED March 27, 2028 001
PED March 27, 2028 001
PED March 27, 2028 002
PED March 27, 2028 002
PED March 27, 2028 003
PED March 27, 2028 003
PED March 27, 2028 004
PED March 27, 2028 004
ODE* September 21, 2029 001
ODE* September 21, 2029 001
ODE* September 21, 2029 002
ODE* September 21, 2029 002
ODE* September 21, 2029 003
ODE* September 21, 2029 003
ODE* September 21, 2029 004
ODE* September 21, 2029 004
PED March 21, 2030 001
PED March 21, 2030 001
PED March 21, 2030 002
PED March 21, 2030 002
PED March 21, 2030 003
PED March 21, 2030 003
PED March 21, 2030 004
PED March 21, 2030 004
ODE* May 29, 2031 001
ODE* May 29, 2031 001
ODE* May 29, 2031 001
ODE* May 29, 2031 002
ODE* May 29, 2031 002
ODE* May 29, 2031 002
ODE* May 29, 2031 003
ODE* May 29, 2031 003
ODE* May 29, 2031 003
ODE* May 29, 2031 004
ODE* May 29, 2031 004
ODE* May 29, 2031 004
PED November 29, 2031 001
PED November 29, 2031 001
PED November 29, 2031 001
PED November 29, 2031 002
PED November 29, 2031 002
PED November 29, 2031 002
PED November 29, 2031 003
PED November 29, 2031 003
PED November 29, 2031 003
PED November 29, 2031 004
PED November 29, 2031 004
PED November 29, 2031 004

Approval history

Source: Drugs@FDA
Most recent submissions on application 218160.
Type No. Action Status Date Review
Supplement 7 Efficacy Approved July 14, 2026 Standard
Supplement 6 Efficacy Approved November 20, 2025 Priority
Supplement 5 Labeling Approved November 20, 2025 Standard
Supplement 4 Labeling Approved December 18, 2024 Standard
Supplement 3 Efficacy Approved September 27, 2024 Standard
Supplement 2 Efficacy Approved September 27, 2024 Priority
Supplement 1 Efficacy Approved June 12, 2024 Standard
Original application 1 Type 3 - New Dosage Form Approved April 10, 2024 Standard

Review documents

  • 0 · Supplement · July 29, 2026
  • 0 · Supplement · July 15, 2026
  • 0 · Supplement · November 21, 2025
  • 0 · Supplement · November 21, 2025
  • 0 · Supplement · November 21, 2025
  • 0 · Supplement · November 21, 2025
  • 0 · Original application · March 28, 2025
  • 0 · Supplement · December 19, 2024
  • 0 · Supplement · December 19, 2024
  • 0 · Supplement · September 30, 2024
  • 0 · Supplement · September 30, 2024
  • 0 · Supplement · September 30, 2024
  • 0 · Supplement · September 30, 2024
  • 0 · Supplement · June 13, 2024
  • 0 · Supplement · June 12, 2024
  • 0 · Original application · April 12, 2024
  • 0 · Original application · April 10, 2024

Adverse event reports

Source: openFDA FAERS
0
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0002-5340-60 0002-5340 Eli Lilly and Company 60 TABLET, COATED in 1 BOTTLE (0002-5340-60) April 10, 2024
0002-5562-60 0002-5562 Eli Lilly and Company 60 TABLET, COATED in 1 BOTTLE (0002-5562-60) April 10, 2024
0002-6082-60 0002-6082 Eli Lilly and Company 60 TABLET, COATED in 1 BOTTLE (0002-6082-60) April 10, 2024
0002-6120-60 0002-6120 Eli Lilly and Company 60 TABLET, COATED in 1 BOTTLE (0002-6120-60) April 10, 2024
0002-5340 0002-5340 Eli Lilly and Company — April 10, 2024
0002-5562 0002-5562 Eli Lilly and Company — April 10, 2024
0002-6082 0002-6082 Eli Lilly and Company — April 10, 2024
0002-6120 0002-6120 Eli Lilly and Company — April 10, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 11 sections on this page.