nexletol

Generic: bempedoic acid

Labeler: esperion therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nexletol
Generic Name bempedoic acid
Labeler esperion therapeutics, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bempedoic acid 180 mg/1

Manufacturer
Esperion Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 72426-118
Product ID 72426-118_75423e10-bf22-4ef2-81de-fa6451541020
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211616
Listing Expiration 2027-12-31
Marketing Start 2020-03-06

Pharmacologic Class

Established (EPC)
adenosine triphosphate-citrate lyase inhibitor [epc]
Mechanism of Action
adenosine triphosphate-citrate lyase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72426118
Hyphenated Format 72426-118

Supplemental Identifiers

RxCUI
2282408 2282414
UPC
0372426118035
UNII
1EJ6Z6Q368
NUI
N0000193913 N0000193914

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nexletol (source: ndc)
Generic Name bempedoic acid (source: ndc)
Application Number NDA211616 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-03)
  • 7 TABLET, FILM COATED in 1 BLISTER PACK (72426-118-99)
source: ndc

Packages (2)

72426-118-03 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-03) 72426-118-99 7 TABLET, FILM COATED in 1 BLISTER PACK (72426-118-99)

Ingredients (1)

bempedoic acid (180 mg/1)

Linked Drug Pages (1)

Nexletol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "75423e10-bf22-4ef2-81de-fa6451541020", "openfda": {"nui": ["N0000193913", "N0000193914"], "upc": ["0372426118035"], "unii": ["1EJ6Z6Q368"], "rxcui": ["2282408", "2282414"], "spl_set_id": ["88d06d89-a3da-40b4-b273-8f4f7d56c4c9"], "pharm_class_epc": ["Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC]"], "pharm_class_moa": ["Adenosine Triphosphate-Citrate Lyase Inhibitors [MoA]"], "manufacturer_name": ["Esperion Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-03)", "package_ndc": "72426-118-03", "marketing_start_date": "20200306"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BLISTER PACK (72426-118-99)", "package_ndc": "72426-118-99", "marketing_start_date": "20200306"}], "brand_name": "Nexletol", "product_id": "72426-118_75423e10-bf22-4ef2-81de-fa6451541020", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC]", "Adenosine Triphosphate-Citrate Lyase Inhibitors [MoA]"], "product_ndc": "72426-118", "generic_name": "Bempedoic Acid", "labeler_name": "Esperion Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nexletol", "active_ingredients": [{"name": "BEMPEDOIC ACID", "strength": "180 mg/1"}], "application_number": "NDA211616", "marketing_category": "NDA", "marketing_start_date": "20200306", "listing_expiration_date": "20271231"}