Home NDC 0006-0335 BELSOMRA
Product NDC 0006-0335
11-digit product format 000060335
Labeler code 0006
Product ID 0006-0335_21306af5-e07a-4f8e-8f59-3e0aacc53102
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name suvorexant
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA204569
Marketing category NDA
Marketing start 2014-08-29
Substance SUVOREXANT
Active strength 20 mg/1
Pharmacologic classes Cytochrome P450 3A Inhibitors [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [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 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204569-001 BELSOMRA SUVOREXANT 5MG TABLET / ORAL RLD 2014-08-13 N204569-002 BELSOMRA SUVOREXANT 10MG TABLET / ORAL RLD 2014-08-13 N204569-003 BELSOMRA SUVOREXANT 15MG TABLET / ORAL RLD 2014-08-13 N204569-004 BELSOMRA SUVOREXANT 20MG TABLET / ORAL RLD, RS 2014-08-13
Orange Book patents# Current patent rows page 1 of 1 · 16 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204569-001 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 N204569-001 10098892 2033-05-29 Drug product 2018-10-17 N204569-001 11980623 2033-05-29 Drug product 2024-05-20 N204569-001 12599610 2033-05-29 Drug product 2026-06-17 N204569-002 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 N204569-002 10098892 2033-05-29 Drug product 2018-10-17 N204569-002 11980623 2033-05-29 Drug product 2024-05-20 N204569-002 12599610 2033-05-29 Drug product 2026-06-17 N204569-003 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 N204569-003 10098892 2033-05-29 Drug product 2018-10-17 N204569-003 11980623 2033-05-29 Drug product 2024-05-20 N204569-003 12599610 2033-05-29 Drug product 2026-06-17 N204569-004 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 N204569-004 10098892 2033-05-29 Drug product 2018-10-17 N204569-004 11980623 2033-05-29 Drug product 2024-05-20 N204569-004 12599610 2033-05-29 Drug product 2026-06-17
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 5 · 168 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 2026-08-18 06:07:40 2026-07 N204569-001 BELSOMRA 5MG TABLET / ORAL RLD 2014-08-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-002 BELSOMRA 10MG TABLET / ORAL RLD 2014-08-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-003 BELSOMRA 15MG TABLET / ORAL RLD 2014-08-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-004 BELSOMRA 20MG TABLET / ORAL RLD, RS 2014-08-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204569-001 BELSOMRA 5MG TABLET / ORAL RLD 2014-08-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-002 BELSOMRA 10MG TABLET / ORAL RLD 2014-08-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-003 BELSOMRA 15MG TABLET / ORAL RLD 2014-08-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-004 BELSOMRA 20MG TABLET / ORAL RLD, RS 2014-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-001 BELSOMRA 5MG TABLET / ORAL RLD 2014-08-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-002 BELSOMRA 10MG TABLET / ORAL RLD 2014-08-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-003 BELSOMRA 15MG TABLET / ORAL RLD 2014-08-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-004 BELSOMRA 20MG TABLET / ORAL RLD, RS 2014-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204569-001 BELSOMRA 5MG TABLET / ORAL RLD 2014-08-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204569-002 BELSOMRA 10MG TABLET / ORAL RLD 2014-08-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204569-003 BELSOMRA 15MG TABLET / ORAL RLD 2014-08-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204569-004 BELSOMRA 20MG TABLET / ORAL RLD, RS 2014-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204569-001 BELSOMRA 5MG TABLET / ORAL RLD 2014-08-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204569-002 BELSOMRA 10MG TABLET / ORAL RLD 2014-08-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204569-003 BELSOMRA 15MG TABLET / ORAL RLD 2014-08-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204569-004 BELSOMRA 20MG TABLET / ORAL RLD, RS 2014-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204569-001 BELSOMRA 5MG TABLET / ORAL RLD 2014-08-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204569-002 BELSOMRA 10MG TABLET / ORAL RLD 2014-08-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204569-003 BELSOMRA 15MG TABLET / ORAL RLD 2014-08-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204569-004 BELSOMRA 20MG TABLET / ORAL RLD, RS 2014-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204569-001 BELSOMRA 5MG TABLET / ORAL RLD 2014-08-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204569-002 BELSOMRA 10MG TABLET / ORAL RLD 2014-08-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204569-003 BELSOMRA 15MG TABLET / ORAL RLD 2014-08-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204569-004 BELSOMRA 20MG TABLET / ORAL RLD, RS 2014-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204569-001 BELSOMRA 5MG TABLET / ORAL RLD 2014-08-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204569-002 BELSOMRA 10MG TABLET / ORAL RLD 2014-08-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204569-003 BELSOMRA 15MG TABLET / ORAL RLD 2014-08-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204569-004 BELSOMRA 20MG TABLET / ORAL RLD, RS 2014-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204569-001 BELSOMRA 5MG TABLET / ORAL RLD 2014-08-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204569-002 BELSOMRA 10MG TABLET / ORAL RLD 2014-08-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204569-003 BELSOMRA 15MG TABLET / ORAL RLD 2014-08-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204569-004 BELSOMRA 20MG TABLET / ORAL RLD, RS 2014-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204569-001 BELSOMRA 5MG TABLET / ORAL RLD 2014-08-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204569-002 BELSOMRA 10MG TABLET / ORAL RLD 2014-08-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204569-003 BELSOMRA 15MG TABLET / ORAL RLD 2014-08-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204569-004 BELSOMRA 20MG TABLET / ORAL RLD, RS 2014-08-13 d8e5a09893c0…
Observed Orange Book patent history# Patent history page 1 of 11 · 404 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N204569-001 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-001 10098892 2033-05-29 Drug product 2018-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-001 11980623 2033-05-29 Drug product 2024-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-001 12599610 2033-05-29 Drug product 2026-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-002 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-002 10098892 2033-05-29 Drug product 2018-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-002 11980623 2033-05-29 Drug product 2024-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-002 12599610 2033-05-29 Drug product 2026-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-003 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-003 10098892 2033-05-29 Drug product 2018-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-003 11980623 2033-05-29 Drug product 2024-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-003 12599610 2033-05-29 Drug product 2026-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-004 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-004 10098892 2033-05-29 Drug product 2018-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-004 11980623 2033-05-29 Drug product 2024-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204569-004 12599610 2033-05-29 Drug product 2026-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204569-001 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-001 10098892 2033-05-29 Drug product 2018-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-001 11980623 2033-05-29 Drug product 2024-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-002 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-002 10098892 2033-05-29 Drug product 2018-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-002 11980623 2033-05-29 Drug product 2024-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-003 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-003 10098892 2033-05-29 Drug product 2018-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-003 11980623 2033-05-29 Drug product 2024-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-004 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-004 10098892 2033-05-29 Drug product 2018-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204569-004 11980623 2033-05-29 Drug product 2024-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-001 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-001 10098892 2033-05-29 Drug product 2018-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-001 11980623 2033-05-29 Drug product 2024-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-002 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-002 10098892 2033-05-29 Drug product 2018-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-002 11980623 2033-05-29 Drug product 2024-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-003 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-003 10098892 2033-05-29 Drug product 2018-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-003 11980623 2033-05-29 Drug product 2024-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-004 7951797 2029-11-20 U-620 Drug substance, Drug product 2014-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-004 10098892 2033-05-29 Drug product 2018-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204569-004 11980623 2033-05-29 Drug product 2024-05-20 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 96 observed states.
Additional Listing Data#
Finished product Yes
Brand name base BELSOMRA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUVOREXANT 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 081L192FO9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1547104 Internal RxNorm lookup 1547110 Internal RxNorm lookup 1547112 Internal RxNorm lookup 1547114 Internal RxNorm lookup 1547116 Internal RxNorm lookup 1547118 Internal RxNorm lookup 1547573 Internal RxNorm lookup 1547575 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 0006-0335-10 BELSOMRA 10 in 1 BLISTER PACK TABLET, FILM COATED 10 21 0006-0335-10 BELSOMRA 1 in 1 CASE TABLET, FILM COATED 1 21 0006-0335-13 BELSOMRA 1 in 1 CASE TABLET, FILM COATED 1 21 0006-0335-13 BELSOMRA 3 in 1 BLISTER PACK TABLET, FILM COATED 3 21 0006-0335-30 BELSOMRA 3 in 1 CARTON TABLET, FILM COATED 3 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded suvorexant ACTIVE INGREDIENT 081L192FO9 BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4 suvorexant ACTIVE MOIETY 081L192FO9 BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4 triacetin INACTIVE INGREDIENT XHX3C3X673 BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-0335 BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] 21 Current NDC, Legacy NDC, 5 package rows 20250323_e5b72731-1acb-45b7-9c13-290ad12d3951.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 0006-0335-10 00006033510 10 in 1 BLISTER PACK Historical 0006-0335-13 00006033513 1 BLISTER PACK in 1 CASE (0006-0335-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2014-08-29 0000-00-00 No No Current 0006-0335-30 00006033530 3 CASE in 1 CARTON (0006-0335-30) / 1 BLISTER PACK in 1 CASE (0006-0335-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 3 case 2014-08-29 0000-00-00 No No Current