Home NDC 0002-5340 RETEVMO
Product NDC 0002-5340
11-digit product format 000025340
Labeler code 0002
Product ID 0002-5340_7481a510-805c-4f99-b6ae-7b44e70f5f55
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 40 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218160-001 RETEVMO SELPERCATINIB 40MG TABLET / ORAL RLD 2024-04-10 N218160-002 RETEVMO SELPERCATINIB 80MG TABLET / ORAL RLD 2024-04-10 N218160-003 RETEVMO SELPERCATINIB 120MG TABLET / ORAL RLD 2024-04-10 N218160-004 RETEVMO SELPERCATINIB 160MG TABLET / ORAL RLD, RS 2024-04-10
Orange Book patents# Current patent rows page 1 of 1 · 68 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 80 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 68 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N218160-001 RETEVMO 40MG TABLET / ORAL RLD 2024-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 RETEVMO 80MG TABLET / ORAL RLD 2024-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-003 RETEVMO 120MG TABLET / ORAL RLD 2024-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-004 RETEVMO 160MG TABLET / ORAL RLD, RS 2024-04-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218160-001 RETEVMO 40MG TABLET / ORAL RLD 2024-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218160-002 RETEVMO 80MG TABLET / ORAL RLD 2024-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218160-003 RETEVMO 120MG TABLET / ORAL RLD 2024-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218160-004 RETEVMO 160MG TABLET / ORAL RLD, RS 2024-04-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218160-001 RETEVMO 40MG TABLET / ORAL RLD 2024-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218160-002 RETEVMO 80MG TABLET / ORAL RLD 2024-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218160-003 RETEVMO 120MG TABLET / ORAL RLD 2024-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218160-004 RETEVMO 160MG TABLET / ORAL RLD, RS 2024-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218160-001 RETEVMO 40MG TABLET / ORAL RLD 2024-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218160-002 RETEVMO 80MG TABLET / ORAL RLD 2024-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218160-003 RETEVMO 120MG TABLET / ORAL RLD 2024-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218160-004 RETEVMO 160MG TABLET / ORAL RLD, RS 2024-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218160-001 RETEVMO 40MG TABLET / ORAL RLD 2024-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218160-002 RETEVMO 80MG TABLET / ORAL RLD 2024-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218160-003 RETEVMO 120MG TABLET / ORAL RLD 2024-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218160-004 RETEVMO 160MG TABLET / ORAL RLD, RS 2024-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218160-001 RETEVMO 40MG TABLET / ORAL RLD 2024-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218160-002 RETEVMO 80MG TABLET / ORAL RLD 2024-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218160-003 RETEVMO 120MG TABLET / ORAL RLD 2024-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218160-004 RETEVMO 160MG TABLET / ORAL RLD, RS 2024-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218160-001 RETEVMO 40MG TABLET / ORAL RLD 2024-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218160-002 RETEVMO 80MG TABLET / ORAL RLD 2024-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218160-003 RETEVMO 120MG TABLET / ORAL RLD 2024-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218160-004 RETEVMO 160MG TABLET / ORAL RLD, RS 2024-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218160-001 RETEVMO 40MG TABLET / ORAL RLD 2024-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218160-002 RETEVMO 80MG TABLET / ORAL RLD 2024-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218160-003 RETEVMO 120MG TABLET / ORAL RLD 2024-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218160-004 RETEVMO 160MG TABLET / ORAL RLD, RS 2024-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218160-001 RETEVMO 40MG TABLET / ORAL RLD 2024-04-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218160-002 RETEVMO 80MG TABLET / ORAL RLD 2024-04-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218160-003 RETEVMO 120MG TABLET / ORAL RLD 2024-04-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218160-004 RETEVMO 160MG TABLET / ORAL RLD, RS 2024-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218160-001 RETEVMO 40MG TABLET / ORAL RLD 2024-04-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218160-002 RETEVMO 80MG TABLET / ORAL RLD 2024-04-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218160-003 RETEVMO 120MG TABLET / ORAL RLD 2024-04-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218160-004 RETEVMO 160MG TABLET / ORAL RLD, RS 2024-04-10 5bbf6a4d5a75…
Observed Orange Book patent history# Patent history page 1 of 24 · 948 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N218160-001 10112942 2037-10-10 Drug substance, Drug product 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 10137124 2037-10-10 U-3450 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 10137124 2037-10-10 U-3949 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 10137124 2037-10-10 U-3950 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 10137124 2037-10-10 U-3951 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 10172851 2037-10-10 U-3450 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 10172851 2037-10-10 U-3949 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 10172851 2037-10-10 U-3950 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 10172851 2037-10-10 U-3951 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 10112942*PED 2038-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 10137124*PED 2038-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 10172851*PED 2038-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 12138250 2038-10-10 U-3450 2024-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 12138250 2038-10-10 U-3949 2024-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 12138250 2038-10-10 U-3951 2024-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 12138250 2038-10-10 U-3950 2024-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-001 12138250*PED 2039-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 10112942 2037-10-10 Drug substance, Drug product 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 10137124 2037-10-10 U-3450 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 10137124 2037-10-10 U-3949 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 10137124 2037-10-10 U-3950 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 10137124 2037-10-10 U-3951 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 10172851 2037-10-10 U-3450 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 10172851 2037-10-10 U-3949 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 10172851 2037-10-10 U-3950 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 10172851 2037-10-10 U-3951 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 10112942*PED 2038-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 10137124*PED 2038-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 10172851*PED 2038-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 12138250 2038-10-10 U-3450 2024-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 12138250 2038-10-10 U-3951 2024-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 12138250 2038-10-10 U-3950 2024-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 12138250 2038-10-10 U-3949 2024-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-002 12138250*PED 2039-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-003 10112942 2037-10-10 Drug substance, Drug product 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-003 10137124 2037-10-10 U-3450 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-003 10137124 2037-10-10 U-3949 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-003 10137124 2037-10-10 U-3950 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-003 10137124 2037-10-10 U-3951 2024-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218160-003 10172851 2037-10-10 U-3450 2024-05-09 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 13 · 504 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base RETEVMO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SELPERCATINIB 40 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0002-5340-60 RETEVMO 60 in 1 BOTTLE TABLET, COATED 60 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0002-5340 RETEVMO (SELPERCATINIB) CAPSULE RETEVMO (SELPERCATINIB) TABLET, COATED [ELI LILLY AND COMPANY] 18 Current NDC, 1 package rows 20250103_7fa848ba-a59c-4144-9f52-64d090f4d828.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0002-5340-60 00002534060 60 TABLET, COATED in 1 BOTTLE (0002-5340-60) 2024-04-10 No No Current