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United States · US · US:0006-0033_21306af5-e07a-4f8e-8f59-3e0aacc53102
BELSOMRA
Orange BookUNIISPLATC N05CJ01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeN05CJ01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100060033131 BLISTER PACK in 1 CASE (0006-0033-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1100060033303 CASE in 1 CARTON (0006-0033-30) / 1 BLISTER PACK in 1 CASE (0006-0033-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
081L192FO9
SUVOREXANT
RxCUI 1547099
Orange Book
N204569
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "081L192FO9",
"rxcui": "1547099",
"inchikey": "JYTNQNCOQXFQPK-MRXNPFEDSA-N",
"display_name": "SUVOREXANT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e5b72731-1acb-45b7-9c13-290ad12d3951": {
"match": "brand_token",
"title": "BELSOMRA (SUVOREXANT) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]",
"spl_version": "21",
"published_date": "2025-03-24"
}
},
"productid": "0006-0033_21306af5-e07a-4f8e-8f59-3e0aacc53102",
"productndc": "0006-0033",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204569",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Aug 13, 2014"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Aug 13, 2014"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "15MG",
"product_no": "003",
"approval_date": "Aug 13, 2014"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG",
"product_no": "004",
"approval_date": "Aug 13, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SUVOREXANT",
"proprietary_name": "BELSOMRA",
"active_ingred_unit": "mg/1",
"application_number": "NDA204569",
"marketing_category": "NDA",
"nonproprietary_name": "suvorexant",
"start_marketing_date": "20140829",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05CJ01.
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