Home NDC 80491-7825-3 QUVIVIQ
Product NDC 80491-7825
Requested package NDC 80491-7825-3
11-digit product format 804917825
Labeler code 80491
Product ID 80491-7825_10e24e38-5645-433d-a160-82f4ed5b6dfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Daridorexant
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Idorsia Pharmaceuticals Ltd
Application NDA214985
Marketing category NDA
Marketing start 2022-04-07
Substance DARIDOREXANT
Active strength 25 mg/1
Pharmacologic classes Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]
DEA schedule CIV
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 43 .
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 N214985-001 QUVIVIQ DARIDOREXANT HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 N214985-002 QUVIVIQ DARIDOREXANT HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214985-001 9732075 2033-06-03 U-620 Drug substance, Drug product 2022-05-03 N214985-001 10023560 2034-12-02 U-620 2022-05-03 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 N214985-002 9732075 2033-06-03 U-620 Drug substance, Drug product 2022-05-03 N214985-002 10023560 2034-12-02 U-620 2022-05-03 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 · 62 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 2026-09-14 22:38:34 2026-08 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214985-001 QUVIVIQ EQ 25MG BASE TABLET / ORAL RLD 2022-04-07 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N214985-002 QUVIVIQ EQ 50MG BASE TABLET / ORAL RLD, RS 2022-04-07 ea1830bbd6c7…
Observed Orange Book patent history# Patent history page 1 of 5 · 186 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N214985-001 9732075 2033-06-03 U-620 Drug substance, Drug product 2022-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214985-001 10023560 2034-12-02 U-620 2022-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214985-002 9732075 2033-06-03 U-620 Drug substance, Drug product 2022-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214985-002 10023560 2034-12-02 U-620 2022-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214985-001 9732075 2033-06-03 U-620 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214985-001 10023560 2034-12-02 U-620 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214985-002 9732075 2033-06-03 U-620 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214985-002 10023560 2034-12-02 U-620 2022-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214985-001 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214985-001 10023560 2034-12-02 U-620 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214985-002 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214985-002 10023560 2034-12-02 U-620 2022-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-001 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-001 10023560 2034-12-02 U-620 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-002 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-002 10023560 2034-12-02 U-620 2022-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214985-001 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214985-001 10023560 2034-12-02 U-620 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214985-002 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214985-002 10023560 2034-12-02 U-620 2022-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-001 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-001 10023560 2034-12-02 U-620 2022-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-002 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-002 10023560 2034-12-02 U-620 2022-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214985-002 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214985-001 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214985-001 10023560 2034-12-02 U-620 2022-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214985-001 9790208 2034-12-02 Drug substance, Drug product 2022-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214985-002 9732075 2033-06-12 U-620 Drug substance, Drug product 2022-05-03 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 100 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base QUVIVIQ
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DARIDOREXANT 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LMQ24G57E9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2591502 Internal RxNorm lookup 2591508 Internal RxNorm lookup 2599096 Internal RxNorm lookup 2599098 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 80491-7825-1 QUVIVIQ 7 in 1 BLISTER PACK TABLET, FILM COATED 7 13 80491-7825-1 QUVIVIQ 1 in 1 CARTON TABLET, FILM COATED 1 13 80491-7825-2 QUVIVIQ 1 in 1 CARTON TABLET, FILM COATED 1 13 80491-7825-2 QUVIVIQ 7 in 1 BLISTER PACK TABLET, FILM COATED 7 13 80491-7825-3 QUVIVIQ 30 in 1 BOTTLE TABLET, FILM COATED 30 13 80491-7825-3 QUVIVIQ 1 in 1 CARTON TABLET, FILM COATED 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80491-7825 QUVIVIQ (DARIDOREXANT) TABLET, FILM COATED [IDORSIA PHARMACEUTICALS LTD] 12 Current NDC, Legacy NDC, 6 package rows 20241013_3a2d1503-b816-40c9-9fac-7e03c5a3bcef.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 80491-7825-3 80491782503 1 BOTTLE in 1 CARTON (80491-7825-3) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2022-04-07 0000-00-00 No No Current