Home NDC 62856-405 DAYVIGO
Product NDC 62856-405
11-digit product format 628560405
Labeler code 62856
Product ID 62856-405_c82838dc-6934-4541-8a02-bd44ee5bb82a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lemborexant
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Eisai Inc.
Application NDA212028
Marketing category NDA
Marketing start 2020-04-07
Substance LEMBOREXANT
Active strength 5 mg/1
Pharmacologic classes Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base DAYVIGO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEMBOREXANT 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0K5743G68X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2272408 Internal RxNorm lookup 2272414 Internal RxNorm lookup 2288425 Internal RxNorm lookup 2288427 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 62856-405-10 DAYVIGO 10 in 1 BLISTER PACK TABLET, FILM COATED 10 39 62856-405-10 DAYVIGO 1 in 1 CARTON TABLET, FILM COATED 1 39 62856-405-30 DAYVIGO 30 in 1 BOTTLE TABLET, FILM COATED 30 39 62856-405-90 DAYVIGO 90 in 1 BOTTLE TABLET, FILM COATED 90 39
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62856-405 DAYVIGO (LEMBOREXANT) TABLET, FILM COATED [EISAI INC.] 39 Current NDC, Legacy NDC, 4 package rows 20250303_7074cb65-77b3-45d2-8e8d-da8dc0f70bfd.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 Units Marketing start Marketing end Sample Exclude flag Status 62856-405-10 62856040510 1 BLISTER PACK in 1 CARTON (62856-405-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2020-04-07 0000-00-00 Yes No Current 62856-405-30 62856040530 30 TABLET, FILM COATED in 1 BOTTLE (62856-405-30) 2020-04-07 0000-00-00 No No Current 62856-405-90 62856040590 90 TABLET, FILM COATED in 1 BOTTLE (62856-405-90) 2020-04-07 0000-00-00 No No Current