Home Applications 212028 Application 212028
Type NDA
Sponsor EISAI INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DAYVIGO LEMBOREXANT TABLET;ORAL 5MG Yes No 002 DAYVIGO LEMBOREXANT TABLET;ORAL 10MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212028-001 DAYVIGO LEMBOREXANT 5MG TABLET / ORAL RLD 2020-04-07 N212028-002 DAYVIGO LEMBOREXANT 10MG TABLET / ORAL RLD, RS 2020-04-07
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212028-001 8268848 2031-09-20 U-2791 Drug substance, Drug product 2020-05-05 N212028-001 10188652 2035-10-21 U-2791 Drug product 2020-05-05 N212028-001 10702529 2035-10-21 Drug product 2024-03-22 N212028-001 11026944 2035-10-21 Drug product 2024-03-22 N212028-002 8268848 2031-09-20 U-2791 Drug substance, Drug product 2020-05-05 N212028-002 10188652 2035-10-21 U-2791 Drug product 2020-05-05 N212028-002 10702529 2035-10-21 Drug product 2024-03-22 N212028-002 11026944 2035-10-21 Drug product 2024-03-22
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N212028-001 M-293 2026-04-20 N212028-002 M-293 2026-04-20
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.
Product history page 1 of 2 · 74 observed 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 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212028-001 DAYVIGO 5MG TABLET / ORAL RLD 2020-04-07 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212028-002 DAYVIGO 10MG TABLET / ORAL RLD, RS 2020-04-07 87673890dc5c…
Observed Orange Book patent history# Patent history page 1 of 6 · 208 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 N212028-001 8268848 2031-09-20 U-2791 Drug substance, Drug product 2020-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212028-001 10188652 2035-10-21 U-2791 Drug product 2020-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212028-001 10702529 2035-10-21 Drug product 2024-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212028-001 11026944 2035-10-21 Drug product 2024-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212028-002 8268848 2031-09-20 U-2791 Drug substance, Drug product 2020-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212028-002 10188652 2035-10-21 U-2791 Drug product 2020-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212028-002 10702529 2035-10-21 Drug product 2024-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212028-002 11026944 2035-10-21 Drug product 2024-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212028-001 8268848 2031-09-20 U-2791 Drug substance, Drug product 2020-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212028-001 10188652 2035-10-21 U-2791 Drug product 2020-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212028-001 10702529 2035-10-21 Drug product 2024-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212028-001 11026944 2035-10-21 Drug product 2024-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212028-002 8268848 2031-09-20 U-2791 Drug substance, Drug product 2020-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212028-002 10188652 2035-10-21 U-2791 Drug product 2020-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212028-002 10702529 2035-10-21 Drug product 2024-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212028-002 11026944 2035-10-21 Drug product 2024-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212028-001 8268848 2031-09-20 U-2791 Drug substance, Drug product 2020-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212028-001 10188652 2035-10-21 U-2791 Drug product 2020-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212028-001 10702529 2035-10-21 Drug product 2024-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212028-001 11026944 2035-10-21 Drug product 2024-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212028-002 8268848 2031-09-20 U-2791 Drug substance, Drug product 2020-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212028-002 10188652 2035-10-21 U-2791 Drug product 2020-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212028-002 10702529 2035-10-21 Drug product 2024-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212028-002 11026944 2035-10-21 Drug product 2024-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212028-001 8268848 2031-09-20 U-2791 Drug substance, Drug product 2020-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212028-001 10188652 2035-10-21 U-2791 Drug product 2020-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212028-001 10702529 2035-10-21 Drug product 2024-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212028-001 11026944 2035-10-21 Drug product 2024-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212028-002 8268848 2031-09-20 U-2791 Drug substance, Drug product 2020-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212028-002 10188652 2035-10-21 U-2791 Drug product 2020-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212028-002 10702529 2035-10-21 Drug product 2024-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212028-002 11026944 2035-10-21 Drug product 2024-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212028-001 8268848 2031-09-20 U-2791 Drug substance, Drug product 2020-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212028-001 10188652 2035-10-21 U-2791 Drug product 2020-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212028-001 10702529 2035-10-21 Drug product 2024-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212028-001 11026944 2035-10-21 Drug product 2024-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212028-002 8268848 2031-09-20 U-2791 Drug substance, Drug product 2020-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212028-002 10188652 2035-10-21 U-2791 Drug product 2020-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212028-002 10702529 2035-10-21 Drug product 2024-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212028-002 11026944 2035-10-21 Drug product 2024-03-22 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 114 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 29 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 62856-405 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-405 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-405 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-405 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-405 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-405 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-405 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-405 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-405 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-405 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-410 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-410 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-410 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-410 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-410 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-410 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-410 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-410 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-410 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-410 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-455 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-455 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-455 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-455 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-455 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-455 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-455 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-455 DAYVIGO lemborexant Eisai Inc. NDA Current 62856-455 DAYVIGO lemborexant Eisai Inc. NDA Current