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United States · US · US:68968-0173_ae8030f1-3ed5-40cf-a726-de4c14ee8c1c
SECUADO
Orange BookUNIISPLATC N05AH05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNoven Therapeutics, LLC
CountryUS (United States)
ATC codeN05AH05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11689680173330 POUCH in 1 CARTON (68968-0173-3) / 1 d in 1 POUCH
- ndc1168968017377 POUCH in 1 CARTON (68968-0173-7) / 1 d in 1 POUCH
Annotations
UNII (FDA Substance ID)
JKZ19V908O
ASENAPINE
RxCUI 784649
Orange Book
N212268
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "JKZ19V908O",
"rxcui": "784649",
"inchikey": "VSWBSWWIRNCQIJ-HUUCEWRRSA-N;VSWBSWWIRNCQIJ-GJZGRUSLSA-N",
"display_name": "ASENAPINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TRANSDERMAL",
"spl_meta": {
"685eaf44-5944-4f38-afba-0a4fc0b3462b": {
"match": "brand_token",
"title": "SECUADO (ASENAPINE) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]",
"spl_version": "13",
"published_date": "2025-02-03"
}
},
"productid": "68968-0173_ae8030f1-3ed5-40cf-a726-de4c14ee8c1c",
"productndc": "68968-0173",
"dosage_form": "FILM, EXTENDED RELEASE",
"orange_book": {
"appl_no": "212268",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "3.8MG/24HR",
"product_no": "001",
"approval_date": "Oct 11, 2019"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5.7MG/24HR",
"product_no": "002",
"approval_date": "Oct 11, 2019"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "7.6MG/24HR",
"product_no": "003",
"approval_date": "Oct 11, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ASENAPINE",
"proprietary_name": "SECUADO",
"active_ingred_unit": "mg/d",
"application_number": "NDA212268",
"marketing_category": "NDA",
"nonproprietary_name": "ASENAPINE",
"start_marketing_date": "20200212",
"active_numerator_strength": "5.7"
}Related drugs
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