Home NDC 70183-125-84 Xermelo
Product NDC 70183-125
Requested package NDC 70183-125-84
11-digit product format 701830125
Labeler code 70183
Product ID 70183-125_4d71b74f-8d8b-4701-ba16-08c7c4d8a7f6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name telotristat ethyl
Dosage form TABLET
Route ORAL
Labeler Lexicon Pharmaceuticals, Inc.
Application NDA208794
Marketing category NDA
Marketing start 2017-03-01
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70183-125 70183-125-84 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 2026-02-19 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…2022-09-29 23:25 UTC 2022-09 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208794-001 XERMELO EQ 250MG BASE TABLET / ORAL RLD, RS 2017-02-28 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 6 · 205 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208794-001 7553840 2027-12-11 Drug substance 2017-03-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208794-001 7968559 2027-12-11 U-1979 2017-03-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208794-001 8653094 2028-12-19 U-1979 2017-03-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208794-001 8193204 2031-02-27 Drug substance 2017-03-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208794-001 7709493 2031-02-28 U-1979 Drug substance 2017-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208794-001 7553840 2027-12-11 Drug substance 2017-03-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208794-001 7968559 2027-12-11 U-1979 2017-03-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208794-001 8653094 2028-12-19 U-1979 2017-03-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208794-001 8193204 2031-02-27 Drug substance 2017-03-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208794-001 7709493 2031-02-28 U-1979 Drug substance 2017-03-23 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 53 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Xermelo
Listing expiration 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70183-125 XERMELO (TELOTRISTAT ETHYL) TABLET [LEXICON PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 3 package rows 20221027_f11c21f8-f725-445e-b38e-1e4c5b05bcc6.zip 70183-125 XERMELO (TELOTRISTAT ETHYL) TABLET [LEXICON PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 3 package rows 20221027_f9108ac3-ca6e-4faf-9d04-953abb64d072.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 70183-125-84 70183012584 4 BOX in 1 CASE (70183-125-84) > 7 BLISTER PACK in 1 BOX (70183-125-21) > 3 TABLET in 1 BLISTER PACK (70183-125-03) 4 box 2017-03-01 0000-00-00 No No Current