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 ID: 72426-118_17feabb8-efcd-4e8a-b78c-a17b54e9f597
• NDC: 72426-118
• Product Type: Human Prescription Drug
• Proprietary Name: Nexletol
• Generic Name: Bempedoic Acid
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2020-03-06
• Marketing Category: NDA / NDA
• Application Number: NDA211616
• Labeler Name: Esperion Therapeutics, Inc.
• Substance Name: BEMPEDOIC ACID
• Active Ingredient Strength: 180 mg/1
• Pharm Classes: Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC], Adenosine Triphosphate-Citrate Lyase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 72426-118-03

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-03)

• Marketing Start Date: 2020-03-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72426-118-09 [72426011809]

Nexletol TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211616
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-06

NDC 72426-118-99 [72426011899]

Nexletol TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211616
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-06

NDC 72426-118-03 [72426011803]

Nexletol TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211616
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-03-06

Drug Details

Active Ingredients

Ingredient	Strength
BEMPEDOIC ACID	180 mg/1

OpenFDA Data

• SPL SET ID: 88d06d89-a3da-40b4-b273-8f4f7d56c4c9
• Manufacturer:
  • Esperion Therapeutics, Inc.
• UNII:
  • 1EJ6Z6Q368
• RxNorm Concept Unique ID - RxCUI:
  • 2282408
  • 2282414
• UPC Code:
  • 0372426118035