nexlizet

Generic: bempedoic acid and ezetimibe

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

Drug Facts

Product Profile

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

bempedoic acid 180 mg/1, ezetimibe 10 mg/1

Manufacturer
Esperion Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 72426-818
Product ID 72426-818_d5525891-2cfc-49bf-a684-5d5628dfb9bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211617
Listing Expiration 2027-12-31
Marketing Start 2020-03-09

Pharmacologic Class

Established (EPC)
adenosine triphosphate-citrate lyase inhibitor [epc] dietary cholesterol absorption inhibitor [epc]
Mechanism of Action
adenosine triphosphate-citrate lyase inhibitors [moa]
Physiologic Effect
decreased cholesterol absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72426818
Hyphenated Format 72426-818

Supplemental Identifiers

RxCUI
2283230 2283236
UNII
1EJ6Z6Q368 EOR26LQQ24
NUI
N0000193913 N0000193914 N0000008553 N0000175911

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 nexlizet (source: ndc)
Generic Name bempedoic acid and ezetimibe (source: ndc)
Application Number NDA211617 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-818-03)
  • 7 TABLET, FILM COATED in 1 BLISTER PACK (72426-818-99)
source: ndc

Packages (2)

72426-818-03 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-818-03) 72426-818-99 7 TABLET, FILM COATED in 1 BLISTER PACK (72426-818-99)

Ingredients (2)

bempedoic acid (180 mg/1) ezetimibe (10 mg/1)

Linked Drug Pages (1)

Nexlizet ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d5525891-2cfc-49bf-a684-5d5628dfb9bc", "openfda": {"nui": ["N0000193913", "N0000193914", "N0000008553", "N0000175911"], "unii": ["1EJ6Z6Q368", "EOR26LQQ24"], "rxcui": ["2283230", "2283236"], "spl_set_id": ["3fa2108c-0300-47b8-9d34-f762af7c93c6"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC]", "Dietary Cholesterol Absorption 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 (72426-818-03)", "package_ndc": "72426-818-03", "marketing_start_date": "20200309"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BLISTER PACK (72426-818-99)", "package_ndc": "72426-818-99", "marketing_start_date": "20200309"}], "brand_name": "Nexlizet", "product_id": "72426-818_d5525891-2cfc-49bf-a684-5d5628dfb9bc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC]", "Adenosine Triphosphate-Citrate Lyase Inhibitors [MoA]", "Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "72426-818", "generic_name": "Bempedoic Acid and Ezetimibe", "labeler_name": "Esperion Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nexlizet", "active_ingredients": [{"name": "BEMPEDOIC ACID", "strength": "180 mg/1"}, {"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "NDA211617", "marketing_category": "NDA", "marketing_start_date": "20200309", "listing_expiration_date": "20271231"}