FDA.reportPublic FDA data

BELSOMRA

Product NDC
0006-0325
11-digit product format
000060325
Labeler code
0006
Product ID
0006-0325_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
15 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 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204569-001BELSOMRASUVOREXANT5MGTABLET / ORALRLD2014-08-13
N204569-002BELSOMRASUVOREXANT10MGTABLET / ORALRLD2014-08-13
N204569-003BELSOMRASUVOREXANT15MGTABLET / ORALRLD2014-08-13
N204569-004BELSOMRASUVOREXANT20MGTABLET / ORALRLD, RS2014-08-13

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204569-00179517972029-11-20U-620Drug substance, Drug product2014-09-10
N204569-001100988922033-05-29Drug product2018-10-17
N204569-001119806232033-05-29Drug product2024-05-20
N204569-001125996102033-05-29Drug product2026-06-17
N204569-00279517972029-11-20U-620Drug substance, Drug product2014-09-10
N204569-002100988922033-05-29Drug product2018-10-17
N204569-002119806232033-05-29Drug product2024-05-20
N204569-002125996102033-05-29Drug product2026-06-17
N204569-00379517972029-11-20U-620Drug substance, Drug product2014-09-10
N204569-003100988922033-05-29Drug product2018-10-17
N204569-003119806232033-05-29Drug product2024-05-20
N204569-003125996102033-05-29Drug product2026-06-17
N204569-00479517972029-11-20U-620Drug substance, Drug product2014-09-10
N204569-004100988922033-05-29Drug product2018-10-17
N204569-004119806232033-05-29Drug product2024-05-20
N204569-004125996102033-05-29Drug product2026-06-17

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N204569-001BELSOMRA5MGTABLET / ORALRLD2014-08-13a50c72e98297…
2026-08-01 22:54:322026-06N204569-002BELSOMRA10MGTABLET / ORALRLD2014-08-13a50c72e98297…
2026-08-01 22:54:322026-06N204569-003BELSOMRA15MGTABLET / ORALRLD2014-08-13a50c72e98297…
2026-08-01 22:54:322026-06N204569-004BELSOMRA20MGTABLET / ORALRLD, RS2014-08-13a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N204569-00179517972029-11-20U-620Drug substance, Drug product2014-09-10a50c72e98297…
2026-08-01 22:54:322026-06N204569-001100988922033-05-29Drug product2018-10-17a50c72e98297…
2026-08-01 22:54:322026-06N204569-001119806232033-05-29Drug product2024-05-20a50c72e98297…
2026-08-01 22:54:322026-06N204569-001125996102033-05-29Drug product2026-06-17a50c72e98297…
2026-08-01 22:54:322026-06N204569-00279517972029-11-20U-620Drug substance, Drug product2014-09-10a50c72e98297…
2026-08-01 22:54:322026-06N204569-002100988922033-05-29Drug product2018-10-17a50c72e98297…
2026-08-01 22:54:322026-06N204569-002119806232033-05-29Drug product2024-05-20a50c72e98297…
2026-08-01 22:54:322026-06N204569-002125996102033-05-29Drug product2026-06-17a50c72e98297…
2026-08-01 22:54:322026-06N204569-00379517972029-11-20U-620Drug substance, Drug product2014-09-10a50c72e98297…
2026-08-01 22:54:322026-06N204569-003100988922033-05-29Drug product2018-10-17a50c72e98297…
2026-08-01 22:54:322026-06N204569-003119806232033-05-29Drug product2024-05-20a50c72e98297…
2026-08-01 22:54:322026-06N204569-003125996102033-05-29Drug product2026-06-17a50c72e98297…
2026-08-01 22:54:322026-06N204569-00479517972029-11-20U-620Drug substance, Drug product2014-09-10a50c72e98297…
2026-08-01 22:54:322026-06N204569-004100988922033-05-29Drug product2018-10-17a50c72e98297…
2026-08-01 22:54:322026-06N204569-004119806232033-05-29Drug product2024-05-20a50c72e98297…
2026-08-01 22:54:322026-06N204569-004125996102033-05-29Drug product2026-06-17a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BELSOMRASUVOREXANTMerck Sharp & Dohme LLCe5b72731-1acb-45b7-9c13-290ad12d39512025-03-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 204569
application number: NDA204569
ndc (product): 0006-0325

Additional Listing Data#

Finished product
Yes
Brand name base
BELSOMRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUVOREXANT15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
081L192FO9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1547104Internal RxNorm lookup
1547110Internal RxNorm lookup
1547112Internal RxNorm lookup
1547114Internal RxNorm lookup
1547116Internal RxNorm lookup
1547118Internal RxNorm lookup
1547573Internal RxNorm lookup
1547575Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e5b72731-1acb-45b7-9c13-290ad12d3951Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3ead421c-4623-4915-ac3b-17f3566f03a1Product name120141205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-0325-10BELSOMRA10 in 1 BLISTER PACKTABLET, FILM COATED1021
0006-0325-10BELSOMRA1 in 1 CASETABLET, FILM COATED121
0006-0325-13BELSOMRA3 in 1 BLISTER PACKTABLET, FILM COATED321
0006-0325-13BELSOMRA1 in 1 CASETABLET, FILM COATED121
0006-0325-30BELSOMRA3 in 1 CARTONTABLET, FILM COATED321

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0325-10EA - Each0006-03256361fbfa-6671-48b0-a235-4cc03193050812015-03-03
0006-0325-13EA - Each0006-03254f78ade9-886c-4ade-8a55-da58c81f609112018-04-19
0006-0325-30EA - Each0006-032539a4fbb0-6447-4b4d-8b99-3bdf41d9912b12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
suvorexantACTIVE INGREDIENT081L192FO9BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
suvorexantACTIVE MOIETY081L192FO9BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4
triacetinINACTIVE INGREDIENTXHX3C3X673BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0325BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]21Current NDC, Legacy NDC, 5 package rows20250323_e5b72731-1acb-45b7-9c13-290ad12d3951.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1547110Belsomra 10 MG Oral TabletPSNe5b72731-1acb-45b7-9c13-290ad12d395121
1547114Belsomra 15 MG Oral TabletPSNe5b72731-1acb-45b7-9c13-290ad12d395121
1547118Belsomra 20 MG Oral TabletPSNe5b72731-1acb-45b7-9c13-290ad12d395121
1547575Belsomra 5 MG Oral TabletPSNe5b72731-1acb-45b7-9c13-290ad12d395121
1547104suvorexant 10 MG Oral TabletPSNe5b72731-1acb-45b7-9c13-290ad12d395121
1547112suvorexant 15 MG Oral TabletPSNe5b72731-1acb-45b7-9c13-290ad12d395121
1547116suvorexant 20 MG Oral TabletPSNe5b72731-1acb-45b7-9c13-290ad12d395121
1547573suvorexant 5 MG Oral TabletPSNe5b72731-1acb-45b7-9c13-290ad12d395121
1547110suvorexant 10 MG Oral Tablet [Belsomra]SBDe5b72731-1acb-45b7-9c13-290ad12d395121
1547114suvorexant 15 MG Oral Tablet [Belsomra]SBDe5b72731-1acb-45b7-9c13-290ad12d395121
1547118suvorexant 20 MG Oral Tablet [Belsomra]SBDe5b72731-1acb-45b7-9c13-290ad12d395121
1547575suvorexant 5 MG Oral Tablet [Belsomra]SBDe5b72731-1acb-45b7-9c13-290ad12d395121
1547104suvorexant 10 MG Oral TabletSCDe5b72731-1acb-45b7-9c13-290ad12d395121
1547112suvorexant 15 MG Oral TabletSCDe5b72731-1acb-45b7-9c13-290ad12d395121
1547116suvorexant 20 MG Oral TabletSCDe5b72731-1acb-45b7-9c13-290ad12d395121
1547573suvorexant 5 MG Oral TabletSCDe5b72731-1acb-45b7-9c13-290ad12d395121
1547110Belsomra 10 MG Oral TabletSYe5b72731-1acb-45b7-9c13-290ad12d395121
1547114Belsomra 15 MG Oral TabletSYe5b72731-1acb-45b7-9c13-290ad12d395121
1547118Belsomra 20 MG Oral TabletSYe5b72731-1acb-45b7-9c13-290ad12d395121
1547575Belsomra 5 MG Oral TabletSYe5b72731-1acb-45b7-9c13-290ad12d395121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-0325-100000603251010 in 1 BLISTER PACKHistorical
0006-0325-13000060325131 BLISTER PACK in 1 CASE (0006-0325-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2014-08-290000-00-00NoNoCurrent
0006-0325-30000060325303 CASE in 1 CARTON (0006-0325-30) / 1 BLISTER PACK in 1 CASE (0006-0325-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 case2014-08-290000-00-00NoNoCurrent