NDC 72426-118

Nexletol

Bempedoic Acid

Nexletol is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Esperion Therapeutics, Inc.. The primary component is Bempedoic Acid.

Product ID72426-118_17feabb8-efcd-4e8a-b78c-a17b54e9f597
NDC72426-118
Product TypeHuman Prescription Drug
Proprietary NameNexletol
Generic NameBempedoic Acid
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-03-06
Marketing CategoryNDA / NDA
Application NumberNDA211616
Labeler NameEsperion Therapeutics, Inc.
Substance NameBEMPEDOIC ACID
Active Ingredient Strength180 mg/1
Pharm ClassesAdenosine Triphosphate-Citrate Lyase Inhibitor [EPC], Adenosine Triphosphate-Citrate Lyase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 72426-118-03

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-03)
Marketing Start Date2020-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72426-118-09 [72426011809]

Nexletol TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA211616
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-06

NDC 72426-118-99 [72426011899]

Nexletol TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA211616
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-06

NDC 72426-118-03 [72426011803]

Nexletol TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA211616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-06

Drug Details

Active Ingredients

IngredientStrength
BEMPEDOIC ACID180 mg/1

OpenFDA Data

SPL SET ID:88d06d89-a3da-40b4-b273-8f4f7d56c4c9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2282408
  • 2282414
  • UPC Code
  • 0372426118035

  • Trademark Results [Nexletol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NEXLETOL
    NEXLETOL
    87847415 not registered Live/Pending
    Esperion Therapeutics, Inc.
    2018-03-23

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