Nexletol (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 30 Tablet Bottle Label

NDC 72426-118-03
Rx only

NEXLETOL®
(bempedoic acid) tablets

Contains 30 Tablets

180 mg

PRINCIPAL DISPLAY PANEL -- 30 Tablet Bottle Label
(click image for full-size original)
NEXLETOL bempedoic acid tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72426-118
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BEMPEDOIC ACID (BEMPEDOIC ACID) BEMPEDOIC ACID 180 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE 101
LACTOSE MONOHYDRATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 180;ESP
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72426-118-03 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:72426-118-09 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:72426-118-99 7 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211616 03/06/2020
Labeler — Esperion Therapeutics, Inc. (029516312)

Revised: 12/2023 Esperion Therapeutics, Inc.

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