Xermelo
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 useInitial U.S. Approval: 2017
Approved
Approval ID
a4ac9d62-887c-4c8f-b04d-a5f31cec7c86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2022
Manufacturers
FDA
TerSera Therapeutics LLC
DUNS: 080226115
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
telotristat ethyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70720-125
Application NumberNDA208794
Product Classification
M
Marketing Category
C73594
G
Generic Name
telotristat ethyl
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2021
FDA Product Classification
INGREDIENTS (10)
telotristat ethylActive
Quantity: 250 mg in 1 1
Code: 8G388563M7
Classification: ACTIB
hydroxypropyl cellulose (90000 wamw)Inactive
Code: UKE75GEA7F
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
polyvinyl alcohol, unspecifiedInactive
Code: 532B59J990
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT