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United States · US · US:50419-541_28aa9af2-2939-46e0-8c9c-af939e81b551
Kerendia
Orange BookUNIISPLATC C03DA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC03DA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11504195410130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-541-01)
- ndc11504195410290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-541-02)
- ndc11504195410610 TABLET, FILM COATED in 1 BLISTER PACK (50419-541-06)
- ndc1150419541707 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-541-70)
Annotations
UNII (FDA Substance ID)
DE2O63YV8R
FINERENONE
RxCUI 2562811
Orange Book
N215341
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "DE2O63YV8R",
"rxcui": "2562811",
"inchikey": "BTBHLEZXCOBLCY-QGZVFWFLSA-N",
"display_name": "FINERENONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fc726765-5d5a-4d6e-b037-b847bda9fb7c": {
"match": "brand_token",
"title": "KERENDIA (FINERENONE) TABLET, FILM COATED KERENDIA (FINERENONE) TABLET [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "13",
"published_date": "2025-09-01"
}
},
"productid": "50419-541_28aa9af2-2939-46e0-8c9c-af939e81b551",
"productndc": "50419-541",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "215341",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Jul 9, 2021"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG",
"product_no": "002",
"approval_date": "Jul 9, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "40MG",
"product_no": "003",
"approval_date": "Jul 11, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FINERENONE",
"proprietary_name": "Kerendia",
"active_ingred_unit": "mg/1",
"application_number": "NDA215341",
"marketing_category": "NDA",
"nonproprietary_name": "finerenone",
"start_marketing_date": "20210709",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code C03DA05.
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