🇺🇸
United States · US · US:0597-7313_86fd1ab2-c0a5-4ab7-8ae7-da8b42c169ca
JASCAYD
Orange BookUNIISPLATC L04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105977313211 BOTTLE, PLASTIC in 1 CARTON (0597-7313-21) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
I5DGT51IB8
NERANDOMILAST
Orange Book
N218764
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "I5DGT51IB8",
"rxcui": null,
"inchikey": "UHYCLWAANUGUMN-SSEXGKCCSA-N",
"display_name": "NERANDOMILAST",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fa1b14c6-957f-d326-5099-911bfe33e391": {
"match": "brand_token",
"title": "JASCAYD (NERANDOMILAST) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
"spl_version": "4",
"published_date": "2026-02-06"
}
},
"productid": "0597-7313_86fd1ab2-c0a5-4ab7-8ae7-da8b42c169ca",
"productndc": "0597-7313",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218764",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "9MG",
"product_no": "001",
"approval_date": "Oct 7, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "18MG",
"product_no": "002",
"approval_date": "Oct 7, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NERANDOMILAST",
"proprietary_name": "JASCAYD",
"active_ingred_unit": "mg/1",
"application_number": "NDA218764",
"marketing_category": "NDA",
"nonproprietary_name": "nerandomilast",
"start_marketing_date": "20251007",
"active_numerator_strength": "18"
}Related drugs
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