FDA.reportPublic FDA data

Xermelo

Product NDC
70720-125
11-digit product format
707200125
Labeler code
70720
Product ID
70720-125_ba59d050-c350-492f-a421-f4b64f6fc60e
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70720-125-22Xermelo21 in 1 BLISTER PACKTABLET215
70720-125-22Xermelo1 in 1 BOXTABLET15
70720-125-85Xermelo4 in 1 CASETABLET45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70720-125-85EA - Each70720-125be89815a-2dd6-4c74-a9d0-9f51d401fb4512022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70720-125XERMELO (TELOTRISTAT ETHYL) TABLET [TERSERA THERAPEUTICS LLC]5Current NDC, Legacy NDC, 3 package rows20221005_a4ac9d62-887c-4c8f-b04d-a5f31cec7c86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1872453telotristat ethyl 250 MG Oral TabletPSNa4ac9d62-887c-4c8f-b04d-a5f31cec7c865
1872458XERMELO 250 MG Oral TabletPSNa4ac9d62-887c-4c8f-b04d-a5f31cec7c865
1872458telotristat ethyl 250 MG Oral Tablet [Xermelo]SBDa4ac9d62-887c-4c8f-b04d-a5f31cec7c865
1872453telotristat ethyl 250 MG Oral TabletSCDa4ac9d62-887c-4c8f-b04d-a5f31cec7c865
1872453telotristat ethyl 250 MG (as telotristat etiprate 328 MG) Oral TabletSYa4ac9d62-887c-4c8f-b04d-a5f31cec7c865
1872458Xermelo 250 MG (as telotristat etiprate 328 MG) Oral TabletSYa4ac9d62-887c-4c8f-b04d-a5f31cec7c865
1872458Xermelo 250 MG Oral TabletSYa4ac9d62-887c-4c8f-b04d-a5f31cec7c865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70720-125-227072001252221 in 1 BLISTER PACKHistorical
70720-125-85707200125854 BOX in 1 CASE (70720-125-85) / 1 BLISTER PACK in 1 BOX (70720-125-22) / 21 TABLET in 1 BLISTER PACK4 box2021-10-010000-00-00NoNoCurrent