🇺🇸
United States · US · US:0078-0867_0f5f8b14-d798-49dd-bfbf-e9643c545c93
KISQALI
Orange BookUNIISPLATC L01EF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL01EF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100780867423 BLISTER PACK in 1 CARTON (0078-0867-42) / 14 TABLET, FILM COATED in 1 BLISTER PACK (0078-0867-14)
Annotations
UNII (FDA Substance ID)
BG7HLX2919
RIBOCICLIB SUCCINATE
RxCUI 1873978
Orange Book
N209092
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "BG7HLX2919",
"rxcui": "1873978",
"inchikey": "NHANOMFABJQAAH-UHFFFAOYSA-N",
"display_name": "RIBOCICLIB SUCCINATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"aaeaef94-f3f5-4367-8ea2-b181d7be2da8": {
"match": "brand_token",
"title": "KISQALI (RIBOCICLIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "27",
"published_date": "2025-12-16"
}
},
"productid": "0078-0867_0f5f8b14-d798-49dd-bfbf-e9643c545c93",
"productndc": "0078-0867",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209092",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE",
"product_no": "001",
"approval_date": "Mar 13, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RIBOCICLIB SUCCINATE",
"proprietary_name": "KISQALI",
"active_ingred_unit": "mg/1",
"application_number": "NDA209092",
"marketing_category": "NDA",
"nonproprietary_name": "ribociclib",
"start_marketing_date": "20170313",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code L01EF02.
Access this data programmatically
Query KISQALI and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.