Home NDC 70720-125 Xermelo
Product NDC 70720-125
11-digit product format 707200125
Labeler code 70720
Product ID 70720-125_8643b325-c079-4319-b751-223180291f0a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name telotristat ethyl
Dosage form TABLET
Route ORAL
Labeler TerSera Therapeutics LLC
Application NDA208794
Marketing category NDA
Marketing start 2020-10-05
Substance TELOTRISTAT ETHYL
Active strength 250 mg/1
Pharmacologic classes Tryptophan Hydroxylase Inhibitor [EPC], Tryptophan Hydroxylase 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208794-001 XERMELO TELOTRISTAT ETIPRATE EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208794-001 7553840 2027-12-11 Drug substance 2017-03-23 N208794-001 7968559 2027-12-11 U-1979 2017-03-23 N208794-001 8653094 2028-12-19 U-1979 2017-03-23 N208794-001 8193204 2031-02-27 Drug substance 2017-03-23 N208794-001 7709493 2031-02-28 U-1979 Drug substance 2017-03-23
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 · 43 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 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 6 · 215 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 N208794-001 7553840 2027-12-11 Drug substance 2017-03-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208794-001 7968559 2027-12-11 U-1979 2017-03-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208794-001 8653094 2028-12-19 U-1979 2017-03-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208794-001 8193204 2031-02-27 Drug substance 2017-03-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208794-001 7709493 2031-02-28 U-1979 Drug substance 2017-03-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208794-001 7553840 2027-12-11 Drug substance 2017-03-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208794-001 7968559 2027-12-11 U-1979 2017-03-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208794-001 8653094 2028-12-19 U-1979 2017-03-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208794-001 8193204 2031-02-27 Drug substance 2017-03-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208794-001 7709493 2031-02-28 U-1979 Drug substance 2017-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208794-001 7553840 2027-12-11 Drug substance 2017-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208794-001 7968559 2027-12-11 U-1979 2017-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208794-001 8653094 2028-12-19 U-1979 2017-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208794-001 8193204 2031-02-27 Drug substance 2017-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208794-001 7709493 2031-02-28 U-1979 Drug substance 2017-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208794-001 7553840 2027-12-11 Drug substance 2017-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208794-001 7968559 2027-12-11 U-1979 2017-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208794-001 8653094 2028-12-19 U-1979 2017-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208794-001 8193204 2031-02-27 Drug substance 2017-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208794-001 7709493 2031-02-28 U-1979 Drug substance 2017-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208794-001 7553840 2027-12-11 Drug substance 2017-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208794-001 7968559 2027-12-11 U-1979 2017-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208794-001 8653094 2028-12-19 U-1979 2017-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208794-001 8193204 2031-02-27 Drug substance 2017-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208794-001 7709493 2031-02-28 U-1979 Drug substance 2017-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208794-001 7553840 2027-12-11 Drug substance 2017-03-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208794-001 7968559 2027-12-11 U-1979 2017-03-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208794-001 8653094 2028-12-19 U-1979 2017-03-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208794-001 8193204 2031-02-27 Drug substance 2017-03-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208794-001 7709493 2031-02-28 U-1979 Drug substance 2017-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208794-001 7553840 2027-12-11 Drug substance 2017-03-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208794-001 7968559 2027-12-11 U-1979 2017-03-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208794-001 8653094 2028-12-19 U-1979 2017-03-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208794-001 8193204 2031-02-27 Drug substance 2017-03-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208794-001 7709493 2031-02-28 U-1979 Drug substance 2017-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208794-001 7553840 2027-12-11 Drug substance 2017-03-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208794-001 7968559 2027-12-11 U-1979 2017-03-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208794-001 8653094 2028-12-19 U-1979 2017-03-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208794-001 8193204 2031-02-27 Drug substance 2017-03-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208794-001 7709493 2031-02-28 U-1979 Drug substance 2017-03-23 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 53 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 Xermelo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TELOTRISTAT ETHYL 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8G388563M7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1872453 Internal RxNorm lookup 1872458 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70720-125-22 Xermelo 21 in 1 BLISTER PACK TABLET 21 5 70720-125-22 Xermelo 1 in 1 BOX TABLET 1 5 70720-125-85 Xermelo 4 in 1 CASE TABLET 4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70720-125 XERMELO (TELOTRISTAT ETHYL) TABLET [TERSERA THERAPEUTICS LLC] 5 Current NDC, Legacy NDC, 3 package rows 20221005_a4ac9d62-887c-4c8f-b04d-a5f31cec7c86.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70720-125-22 70720012522 21 in 1 BLISTER PACK Historical 70720-125-85 70720012585 4 BOX in 1 CASE (70720-125-85) / 1 BLISTER PACK in 1 BOX (70720-125-22) / 21 TABLET in 1 BLISTER PACK 4 box 2021-10-01 0000-00-00 No No Current