belsomra

Generic: suvorexant

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name belsomra
Generic Name suvorexant
Labeler merck sharp & dohme llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

suvorexant 5 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-0005
Product ID 0006-0005_21306af5-e07a-4f8e-8f59-3e0aacc53102
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204569
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2014-08-29

Pharmacologic Class

Established (EPC)
orexin receptor antagonist [epc]
Mechanism of Action
orexin receptor antagonists [moa] p-glycoprotein inhibitors [moa] cytochrome p450 3a inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00060005
Hyphenated Format 0006-0005

Supplemental Identifiers

RxCUI
1547104 1547110 1547112 1547114 1547116 1547118 1547573 1547575
UNII
081L192FO9
NUI
N0000191000 N0000190998 N0000185503 N0000190114

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name belsomra (source: ndc)
Generic Name suvorexant (source: ndc)
Application Number NDA204569 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CASE (0006-0005-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • 3 CASE in 1 CARTON (0006-0005-30) / 1 BLISTER PACK in 1 CASE (0006-0005-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

0006-0005-13 1 BLISTER PACK in 1 CASE (0006-0005-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK 0006-0005-30 3 CASE in 1 CARTON (0006-0005-30) / 1 BLISTER PACK in 1 CASE (0006-0005-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

suvorexant (5 mg/1)

Linked Drug Pages (1)

BELSOMRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21306af5-e07a-4f8e-8f59-3e0aacc53102", "openfda": {"nui": ["N0000191000", "N0000190998", "N0000185503", "N0000190114"], "unii": ["081L192FO9"], "rxcui": ["1547104", "1547110", "1547112", "1547114", "1547116", "1547118", "1547573", "1547575"], "spl_set_id": ["e5b72731-1acb-45b7-9c13-290ad12d3951"], "pharm_class_epc": ["Orexin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Orexin Receptor Antagonists [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CASE (0006-0005-13)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0006-0005-13", "marketing_start_date": "20140829"}, {"sample": false, "description": "3 CASE in 1 CARTON (0006-0005-30)  / 1 BLISTER PACK in 1 CASE (0006-0005-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0006-0005-30", "marketing_start_date": "20140829"}], "brand_name": "BELSOMRA", "product_id": "0006-0005_21306af5-e07a-4f8e-8f59-3e0aacc53102", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A Inhibitors [MoA]", "Orexin Receptor Antagonist [EPC]", "Orexin Receptor Antagonists [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0006-0005", "dea_schedule": "CIV", "generic_name": "suvorexant", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BELSOMRA", "active_ingredients": [{"name": "SUVOREXANT", "strength": "5 mg/1"}], "application_number": "NDA204569", "marketing_category": "NDA", "marketing_start_date": "20140829", "listing_expiration_date": "20261231"}