FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Xermelo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TELOTRISTAT ETHYL250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8G388563M7
Rxcui1872453, 1872458

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
193b315b-8917-4155-b9f6-e513af2f6647Product name120170308

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70183-125-842021-02-09C16284748780-1ba0f9c33-2081-a910-e053-dadaa90a0b85These 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
70183-125-842021-01-29C16284748780-1ba0f9c33-2081-a910-e053-dadaa90a0b85These 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 NDCProductDescriptionFormQuantityStrengthSPL version
70183-125-03Xermelo3 in 1 BLISTER PACKTABLET36
70183-125-21Xermelo7 in 1 BOXTABLET76
70183-125-84Xermelo4 in 1 CASETABLET46
70183-125-22Xermelo21 in 1 BLISTER PACKTABLET213
70183-125-22Xermelo4 in 1 BOXTABLET43
70183-125-85Xermelo4 in 1 CASETABLET43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70183-125-84EA - Each70183-125a0c0f501-b43e-474b-838f-aced1fae1c5312017-04-05
70183-125-85EA - Each70183-125dd66a64f-0548-4c42-a6db-8437812ffad812021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70183-125XERMELO (TELOTRISTAT ETHYL) TABLET [LEXICON PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20221027_f11c21f8-f725-445e-b38e-1e4c5b05bcc6.zip
70183-125XERMELO (TELOTRISTAT ETHYL) TABLET [LEXICON PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20221027_f9108ac3-ca6e-4faf-9d04-953abb64d072.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1872453telotristat ethyl 250 MG Oral TabletPSNf11c21f8-f725-445e-b38e-1e4c5b05bcc66
1872458XERMELO 250 MG Oral TabletPSNf11c21f8-f725-445e-b38e-1e4c5b05bcc66
1872458telotristat ethyl 250 MG Oral Tablet [Xermelo]SBDf11c21f8-f725-445e-b38e-1e4c5b05bcc66
1872453telotristat ethyl 250 MG Oral TabletSCDf11c21f8-f725-445e-b38e-1e4c5b05bcc66
1872453telotristat ethyl 250 MG (as telotristat etiprate 328 MG) Oral TabletSYf11c21f8-f725-445e-b38e-1e4c5b05bcc66
1872458Xermelo 250 MG (as telotristat etiprate 328 MG) Oral TabletSYf11c21f8-f725-445e-b38e-1e4c5b05bcc66
1872458Xermelo 250 MG Oral TabletSYf11c21f8-f725-445e-b38e-1e4c5b05bcc66
1872453telotristat ethyl 250 MG Oral TabletPSNf9108ac3-ca6e-4faf-9d04-953abb64d0723
1872458XERMELO 250 MG Oral TabletPSNf9108ac3-ca6e-4faf-9d04-953abb64d0723
1872458telotristat ethyl 250 MG Oral Tablet [Xermelo]SBDf9108ac3-ca6e-4faf-9d04-953abb64d0723
1872453telotristat ethyl 250 MG Oral TabletSCDf9108ac3-ca6e-4faf-9d04-953abb64d0723
1872453telotristat ethyl 250 MG (as telotristat etiprate 328 MG) Oral TabletSYf9108ac3-ca6e-4faf-9d04-953abb64d0723
1872458Xermelo 250 MG (as telotristat etiprate 328 MG) Oral TabletSYf9108ac3-ca6e-4faf-9d04-953abb64d0723
1872458Xermelo 250 MG Oral TabletSYf9108ac3-ca6e-4faf-9d04-953abb64d0723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70183-125-03701830125033 in 1 BLISTER PACKHistorical
70183-125-21701830125217 in 1 BOXHistorical
70183-125-227018301252221 in 1 BLISTER PACKHistorical
70183-125-84701830125844 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 box2017-03-010000-00-00NoNoCurrent
70183-125-85701830125854 BOX in 1 CASE (70183-125-85) > 4 BLISTER PACK in 1 BOX (70183-125-22) > 21 TABLET in 1 BLISTER PACK4 box2021-02-160000-00-00NoNoCurrent