Home Applications 211617 Application 211617
Type NDA
Sponsor ESPERION THERAPS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NEXLIZET BEMPEDOIC ACID; EZETIMIBE TABLET;ORAL 180MG;10MG Yes 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 N211617-001 NEXLIZET BEMPEDOIC ACID; EZETIMIBE 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211617-001 7335799 2030-12-03 Drug substance 2020-03-06 N211617-001 10912751 2036-03-14 U-3224 2021-10-14 N211617-001 10912751 2036-03-14 U-3884 2021-10-14 N211617-001 11744816 2036-03-14 U-3692 2023-10-03 N211617-001 11744816 2036-03-14 U-3883 2023-10-03 N211617-001 11613511 2040-06-19 Drug substance 2023-04-20 N211617-001 11760714 2040-06-19 Drug product 2023-10-03 N211617-001 11926584 2040-06-19 U-3873 2024-04-09 N211617-001 12398087 2040-06-19 Drug substance, Drug product 2025-09-09 N211617-001 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 N211617-001 I-943 2027-03-22 N211617-001 I-945 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 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211617-001 NEXLIZET 180MG;10MG TABLET / ORAL RLD, RS 2020-02-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 280 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 N211617-001 7335799 2030-12-03 Drug substance 2020-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211617-001 10912751 2036-03-14 U-3884 2021-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211617-001 10912751 2036-03-14 U-3224 2021-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211617-001 11744816 2036-03-14 U-3883 2023-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211617-001 11744816 2036-03-14 U-3692 2023-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211617-001 11613511 2040-06-19 Drug substance 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211617-001 11760714 2040-06-19 Drug product 2023-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211617-001 11926584 2040-06-19 U-3873 2024-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211617-001 12398087 2040-06-19 Drug substance, Drug product 2025-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211617-001 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 N211617-001 7335799 2030-12-03 Drug substance 2020-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211617-001 10912751 2036-03-14 U-3884 2021-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211617-001 10912751 2036-03-14 U-3224 2021-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211617-001 11744816 2036-03-14 U-3883 2023-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211617-001 11744816 2036-03-14 U-3692 2023-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211617-001 11613511 2040-06-19 Drug substance 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211617-001 11760714 2040-06-19 Drug product 2023-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211617-001 11926584 2040-06-19 U-3873 2024-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211617-001 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 N211617-001 12404227 2040-06-19 U-4258 Drug substance 2025-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211617-001 7335799 2030-12-03 Drug substance 2020-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211617-001 10912751 2036-03-14 U-3884 2021-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211617-001 10912751 2036-03-14 U-3224 2021-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211617-001 11744816 2036-03-14 U-3883 2023-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211617-001 11744816 2036-03-14 U-3692 2023-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211617-001 11613511 2040-06-19 Drug substance 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211617-001 11760714 2040-06-19 Drug product 2023-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211617-001 11926584 2040-06-19 U-3873 2024-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211617-001 7335799 2030-12-03 Drug substance 2020-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211617-001 10912751 2036-03-14 U-3884 2021-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211617-001 10912751 2036-03-14 U-3224 2021-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211617-001 11744816 2036-03-14 U-3883 2023-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211617-001 11744816 2036-03-14 U-3692 2023-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211617-001 11613511 2040-06-19 Drug substance 2023-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211617-001 11760714 2040-06-19 Drug product 2023-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211617-001 11926584 2040-06-19 U-3873 2024-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211617-001 7335799 2030-12-03 Drug substance 2020-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211617-001 10912751 2036-03-14 U-3884 2021-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211617-001 10912751 2036-03-14 U-3224 2021-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211617-001 11744816 2036-03-14 U-3883 2023-10-03 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 83 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nexlizet BEMPEDOIC ACID AND EZETIMIBE Esperion Therapeutics, Inc. 3fa2108c-0300-47b8-9d34-f762af7c93c6 2026-06-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 211617 application number: NDA211617 ndc (product): 72426-818
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72426-818 Nexlizet Bempedoic Acid and Ezetimibe Esperion Therapeutics, Inc. NDA Current 72426-818 Nexlizet Bempedoic Acid and Ezetimibe Esperion Therapeutics, Inc. NDA Current 72426-818 Nexlizet Bempedoic Acid and Ezetimibe Esperion Therapeutics, Inc. NDA Current 72426-818 Nexlizet Bempedoic Acid and Ezetimibe Esperion Therapeutics, Inc. NDA Current 72426-818 Nexlizet Bempedoic Acid and Ezetimibe Esperion Therapeutics, Inc. NDA Current