FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUVOREXANT20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii081L192FO9
Rxcui1547104, 1547110, 1547112, 1547114, 1547116, 1547118, 1547573, 1547575

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
0006-0335-10BELSOMRA10 in 1 BLISTER PACKTABLET, FILM COATED1021
0006-0335-10BELSOMRA1 in 1 CASETABLET, FILM COATED121
0006-0335-13BELSOMRA1 in 1 CASETABLET, FILM COATED121
0006-0335-13BELSOMRA3 in 1 BLISTER PACKTABLET, FILM COATED321
0006-0335-30BELSOMRA3 in 1 CARTONTABLET, FILM COATED321

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0335-10EA - Each0006-0335732a4aaa-6ca3-427d-8b44-54942b860d2e12015-03-03
0006-0335-13EA - Each0006-0335ff26ead0-b8f8-4ec3-b1ce-8e9fb7c5ba4412018-04-19
0006-0335-30EA - Each0006-03351ab38626-a0be-4011-83a6-b5827207fecd12015-01-05

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
0006-0335BELSOMRA (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
0006-0335-100000603351010 in 1 BLISTER PACKHistorical
0006-0335-13000060335131 BLISTER PACK in 1 CASE (0006-0335-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2014-08-290000-00-00NoNoCurrent
0006-0335-30000060335303 CASE in 1 CARTON (0006-0335-30) / 1 BLISTER PACK in 1 CASE (0006-0335-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 case2014-08-290000-00-00NoNoCurrent