NDC 70183-125

Xermelo

Telotristat Ethyl

Xermelo is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lexicon Pharmaceuticals, Inc.. The primary component is Telotristat Ethyl.

Product ID70183-125_12e74795-1e89-4f3e-a162-01ab941aca0b
NDC70183-125
Product TypeHuman Prescription Drug
Proprietary NameXermelo
Generic NameTelotristat Ethyl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-03-01
Marketing CategoryNDA / NDA
Application NumberNDA208794
Labeler NameLexicon Pharmaceuticals, Inc.
Substance NameTELOTRISTAT ETHYL
Active Ingredient Strength250 mg/1
Pharm ClassesTryptophan Hydroxylase Inhibitor [EPC],Tryptophan Hydroxylase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70183-125-85

4 BOX in 1 CASE (70183-125-85) > 4 BLISTER PACK in 1 BOX (70183-125-22) > 21 TABLET in 1 BLISTER PACK
Marketing Start Date2021-02-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70183-125-21 [70183012521]

Xermelo TABLET
Marketing CategoryNDA
Application NumberNDA208794
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-01

NDC 70183-125-84 [70183012584]

Xermelo TABLET
Marketing CategoryNDA
Application NumberNDA208794
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-01

NDC 70183-125-03 [70183012503]

Xermelo TABLET
Marketing CategoryNDA
Application NumberNDA208794
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-01

Drug Details

Active Ingredients

IngredientStrength
TELOTRISTAT ETHYL250 mg/1

OpenFDA Data

SPL SET ID:f11c21f8-f725-445e-b38e-1e4c5b05bcc6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1872458
  • 1872453
  • Pharmacological Class

    • Tryptophan Hydroxylase Inhibitor [EPC]
    • Tryptophan Hydroxylase Inhibitors [MoA]

    NDC Crossover Matching brand name "Xermelo" or generic name "Telotristat Ethyl"

    NDCBrand NameGeneric Name
    70183-125Xermelotelotristat ethyl
    70720-125Xermelotelotristat ethyl

    Trademark Results [Xermelo]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XERMELO
    XERMELO
    87320213 not registered Live/Pending
    Lexicon Pharmaceuticals, Inc.
    2017-01-31
    XERMELO
    XERMELO
    86013323 5200148 Live/Registered
    Lexicon Pharmaceuticals, Inc.
    2013-07-17

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