Kerendia

Orange BookUNIISPLATC C03DA05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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

ndc11
5041954201
30 TABLET in 1 BOTTLE, PLASTIC (50419-542-01)
ndc11
5041954202
90 TABLET in 1 BOTTLE, PLASTIC (50419-542-02)
ndc11
5041954206
10 TABLET in 1 BLISTER PACK (50419-542-06)
ndc11
5041954270
7 TABLET in 1 BOTTLE, PLASTIC (50419-542-70)

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": "50419-542_28aa9af2-2939-46e0-8c9c-af939e81b551",
  "productndc": "50419-542",
  "dosage_form": "TABLET",
  "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": "40"
}

Related drugs

Other records sharing ATC code C03DA05.

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