Xermelo

Product NDC: 70183-125
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70183-125	70183-125-85	D	Discontinued by firm		2026-08-03
excluded package	package	70183-125	70183-125-84	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 2 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

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…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70183-125	70183-125-85	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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208794-001	ODE-132	2024-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208794-001	ODE-132	2024-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208794-001	ODE-132	2024-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208794-001	ODE-132	2024-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208794-001	ODE-132	2024-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208794-001	ODE-132	2024-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208794-001	ODE-132	2024-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208794-001	ODE-132	2024-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208794-001	ODE-132	2024-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208794-001	NCE	2022-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208794-001	ODE-132	2024-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208794-001	NCE	2022-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208794-001	ODE-132	2024-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208794-001	NCE	2022-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208794-001	ODE-132	2024-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208794-001	NCE	2022-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208794-001	ODE-132	2024-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208794-001	NCE	2022-02-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208794-001	ODE-132	2024-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208794-001	NCE	2022-02-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208794-001	ODE-132	2024-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208794-001	NCE	2022-02-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208794-001	ODE-132	2024-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208794-001	NCE	2022-02-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208794-001	ODE-132	2024-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208794-001	NCE	2022-02-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208794-001	ODE-132	2024-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208794-001	NCE	2022-02-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208794-001	ODE-132	2024-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208794-001	NCE	2022-02-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208794-001	ODE-132	2024-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208794-001	NCE	2022-02-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208794-001	ODE-132	2024-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208794-001	NCE	2022-02-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208794-001	ODE-132	2024-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208794-001	ODE-132	2024-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208794-001	ODE-132	2024-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208794-001	ODE-132	2024-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208794-001	ODE-132	2024-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208794-001	ODE-132	2024-02-28	`9b2671bbb829…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xermelo	TELOTRISTAT ETHYL	Lexicon Pharmaceuticals, Inc.	f9108ac3-ca6e-4faf-9d04-953abb64d072	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208794 application number: NDA208794 ndc (product): 70183-125
Xermelo	TELOTRISTAT ETHYL	Lexicon Pharmaceuticals, Inc.	f11c21f8-f725-445e-b38e-1e4c5b05bcc6	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208794 application number: NDA208794 ndc (product): 70183-125
Xermelo	TELOTRISTAT ETHYL	TerSera Therapeutics LLC	a4ac9d62-887c-4c8f-b04d-a5f31cec7c86	2022-10-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208794 application number: NDA208794

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f9108ac3-ca6e-4faf-9d04-953abb64d072	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
193b315b-8917-4155-b9f6-e513af2f6647	Product name	1	20170308

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70183-125-84	2021-02-09	C162847	48780-1	ba0f9c33-2081-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use XERMELO safely and effectively. See full prescribing information for XERMELO. XERMELO (telotristat ethyl) tablets, for oral use Initial U.S. Approval: 2017
70183-125-84	2021-01-29	C162847	48780-1	ba0f9c33-2081-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use XERMELO safely and effectively. See full prescribing information for XERMELO. XERMELO (telotristat ethyl) tablets, for oral use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70183-125-03	Xermelo	3 in 1 BLISTER PACK	TABLET	3	6
70183-125-21	Xermelo	7 in 1 BOX	TABLET	7	6
70183-125-84	Xermelo	4 in 1 CASE	TABLET	4	6
70183-125-22	Xermelo	21 in 1 BLISTER PACK	TABLET	21	3
70183-125-22	Xermelo	4 in 1 BOX	TABLET	4	3
70183-125-85	Xermelo	4 in 1 CASE	TABLET	4	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70183-125-84	EA - Each	70183-125	a0c0f501-b43e-474b-838f-aced1fae1c53	1	2017-04-05
70183-125-85	EA - Each	70183-125	dd66a64f-0548-4c42-a6db-8437812ffad8	1	2021-05-05

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8G388563M7	TELOTRISTAT ETHYL	1033805-22-9	TELOTRISTAT ETHYL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1872453	telotristat ethyl 250 MG Oral Tablet	PSN	f11c21f8-f725-445e-b38e-1e4c5b05bcc6	6
1872458	XERMELO 250 MG Oral Tablet	PSN	f11c21f8-f725-445e-b38e-1e4c5b05bcc6	6
1872458	telotristat ethyl 250 MG Oral Tablet [Xermelo]	SBD	f11c21f8-f725-445e-b38e-1e4c5b05bcc6	6
1872453	telotristat ethyl 250 MG Oral Tablet	SCD	f11c21f8-f725-445e-b38e-1e4c5b05bcc6	6
1872453	telotristat ethyl 250 MG (as telotristat etiprate 328 MG) Oral Tablet	SY	f11c21f8-f725-445e-b38e-1e4c5b05bcc6	6
1872458	Xermelo 250 MG (as telotristat etiprate 328 MG) Oral Tablet	SY	f11c21f8-f725-445e-b38e-1e4c5b05bcc6	6
1872458	Xermelo 250 MG Oral Tablet	SY	f11c21f8-f725-445e-b38e-1e4c5b05bcc6	6
1872453	telotristat ethyl 250 MG Oral Tablet	PSN	f9108ac3-ca6e-4faf-9d04-953abb64d072	3
1872458	XERMELO 250 MG Oral Tablet	PSN	f9108ac3-ca6e-4faf-9d04-953abb64d072	3
1872458	telotristat ethyl 250 MG Oral Tablet [Xermelo]	SBD	f9108ac3-ca6e-4faf-9d04-953abb64d072	3
1872453	telotristat ethyl 250 MG Oral Tablet	SCD	f9108ac3-ca6e-4faf-9d04-953abb64d072	3
1872453	telotristat ethyl 250 MG (as telotristat etiprate 328 MG) Oral Tablet	SY	f9108ac3-ca6e-4faf-9d04-953abb64d072	3
1872458	Xermelo 250 MG (as telotristat etiprate 328 MG) Oral Tablet	SY	f9108ac3-ca6e-4faf-9d04-953abb64d072	3
1872458	Xermelo 250 MG Oral Tablet	SY	f9108ac3-ca6e-4faf-9d04-953abb64d072	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70183-125-03	70183012503	3 in 1 BLISTER PACK						Historical
70183-125-21	70183012521	7 in 1 BOX						Historical
70183-125-22	70183012522	21 in 1 BLISTER PACK						Historical
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
70183-125-85	70183012585	4 BOX in 1 CASE (70183-125-85) > 4 BLISTER PACK in 1 BOX (70183-125-22) > 21 TABLET in 1 BLISTER PACK	4 box	2021-02-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xermelo	Lexicon Pharmaceuticals, Inc.	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	6
Xermelo	Lexicon Pharmaceuticals, Inc.	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	3