Home NDC 72426-118-99 Nexletol
Product NDC 72426-118
Requested package NDC 72426-118-99
11-digit product format 724260118
Labeler code 72426
Product ID 72426-118_75423e10-bf22-4ef2-81de-fa6451541020
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bempedoic Acid
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Esperion Therapeutics, Inc.
Application NDA211616
Marketing category NDA
Marketing start 2020-03-06
Substance BEMPEDOIC ACID
Active strength 180 mg/1
Pharmacologic classes Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC], Adenosine Triphosphate-Citrate Lyase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211616-001 NEXLETOL BEMPEDOIC ACID 180MG TABLET / ORAL RLD, RS 2020-02-21
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211616-001 7335799 2030-12-03 Drug substance 2020-03-06 N211616-001 11744816 2036-03-14 U-3883 2024-04-19 N211616-001 11613511 2040-06-19 Drug substance 2023-04-20 N211616-001 11760714 2040-06-19 Drug product 2023-10-03 N211616-001 11926584 2040-06-19 U-3873 2024-04-09 N211616-001 12398087 2040-06-19 Drug substance, Drug product 2025-09-09 N211616-001 12404227 2040-06-19 U-4258 Drug substance 2025-09-09
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211616-001 I-943 2027-03-22 N211616-001 I-944 2027-03-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211616-001 NEXLETOL 180MG TABLET / ORAL RLD, RS 2020-02-21 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 6 · 212 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211616-001 7335799 2030-12-03 Drug substance 2020-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211616-001 11744816 2036-03-14 U-3883 2024-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211616-001 11613511 2040-06-19 Drug substance 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211616-001 11760714 2040-06-19 Drug product 2023-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211616-001 11926584 2040-06-19 U-3873 2024-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211616-001 12398087 2040-06-19 Drug substance, Drug product 2025-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211616-001 12404227 2040-06-19 U-4258 Drug substance 2025-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211616-001 7335799 2030-12-03 Drug substance 2020-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211616-001 11744816 2036-03-14 U-3883 2024-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211616-001 11613511 2040-06-19 Drug substance 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211616-001 11760714 2040-06-19 Drug product 2023-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211616-001 11926584 2040-06-19 U-3873 2024-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211616-001 12398087 2040-06-19 Drug substance, Drug product 2025-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211616-001 12404227 2040-06-19 U-4258 Drug substance 2025-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211616-001 7335799 2030-12-03 Drug substance 2020-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211616-001 11744816 2036-03-14 U-3883 2024-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211616-001 11613511 2040-06-19 Drug substance 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211616-001 11760714 2040-06-19 Drug product 2023-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211616-001 11926584 2040-06-19 U-3873 2024-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211616-001 7335799 2030-12-03 Drug substance 2020-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211616-001 11744816 2036-03-14 U-3883 2024-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211616-001 11613511 2040-06-19 Drug substance 2023-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211616-001 11760714 2040-06-19 Drug product 2023-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211616-001 11926584 2040-06-19 U-3873 2024-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211616-001 7335799 2030-12-03 Drug substance 2020-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211616-001 11744816 2036-03-14 U-3883 2024-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211616-001 11613511 2040-06-19 Drug substance 2023-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211616-001 11760714 2040-06-19 Drug product 2023-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211616-001 11926584 2040-06-19 U-3873 2024-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211616-001 7335799 2030-12-03 Drug substance 2020-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211616-001 11744816 2036-03-14 U-3883 2024-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211616-001 11613511 2040-06-19 Drug substance 2023-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211616-001 11760714 2040-06-19 Drug product 2023-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211616-001 11926584 2040-06-19 U-3873 2024-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211616-001 7335799 2030-12-03 Drug substance 2020-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211616-001 11744816 2036-03-14 U-3883 2024-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211616-001 11613511 2040-06-19 Drug substance 2023-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211616-001 11760714 2040-06-19 Drug product 2023-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211616-001 11926584 2040-06-19 U-3873 2024-04-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211616-001 7335799 2030-12-03 Drug substance 2020-03-06 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 63 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nexletol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BEMPEDOIC ACID 180 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1EJ6Z6Q368 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2282408 Internal RxNorm lookup 2282414 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72426-118-03 Nexletol 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 19 72426-118-99 Nexletol 7 in 1 BLISTER PACK TABLET, FILM COATED 7 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72426-118 NEXLETOL (BEMPEDOIC ACID) TABLET, FILM COATED [ESPERION THERAPEUTICS, INC.] 14 Current NDC, Legacy NDC, 2 package rows 20241207_88d06d89-a3da-40b4-b273-8f4f7d56c4c9.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72426-118-99 72426011899 7 TABLET, FILM COATED in 1 BLISTER PACK (72426-118-99) 2020-03-06 0000-00-00 No No Current