kerendia

Generic: finerenone

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kerendia
Generic Name finerenone
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finerenone 10 mg/1

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-540
Product ID 50419-540_28aa9af2-2939-46e0-8c9c-af939e81b551
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215341
Listing Expiration 2026-12-31
Marketing Start 2021-07-09

Pharmacologic Class

Established (EPC)
nonsteroidal mineralocorticoid-receptor antagonist [epc]
Mechanism of Action
mineralocorticoid receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419540
Hyphenated Format 50419-540

Supplemental Identifiers

RxCUI
2562816 2562822 2562824 2562826 2720069 2720071
UNII
DE2O63YV8R
NUI
N0000193970 N0000000139

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kerendia (source: ndc)
Generic Name finerenone (source: ndc)
Application Number NDA215341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-01)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-02)
  • 10 TABLET, FILM COATED in 1 BLISTER PACK (50419-540-06)
  • 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-70)
source: ndc

Packages (4)

50419-540-01 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-01) 50419-540-02 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-02) 50419-540-06 10 TABLET, FILM COATED in 1 BLISTER PACK (50419-540-06) 50419-540-70 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-70)

Ingredients (1)

finerenone (10 mg/1)

Linked Drug Pages (1)

Kerendia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "28aa9af2-2939-46e0-8c9c-af939e81b551", "openfda": {"nui": ["N0000193970", "N0000000139"], "unii": ["DE2O63YV8R"], "rxcui": ["2562816", "2562822", "2562824", "2562826", "2720069", "2720071"], "spl_set_id": ["fc726765-5d5a-4d6e-b037-b847bda9fb7c"], "pharm_class_epc": ["Nonsteroidal Mineralocorticoid-Receptor Antagonist [EPC]"], "pharm_class_moa": ["Mineralocorticoid Receptor Antagonists [MoA]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-01)", "package_ndc": "50419-540-01", "marketing_start_date": "20210709"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-02)", "package_ndc": "50419-540-02", "marketing_start_date": "20210709"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BLISTER PACK (50419-540-06)", "package_ndc": "50419-540-06", "marketing_start_date": "20250823"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-70)", "package_ndc": "50419-540-70", "marketing_start_date": "20210709"}], "brand_name": "Kerendia", "product_id": "50419-540_28aa9af2-2939-46e0-8c9c-af939e81b551", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Mineralocorticoid Receptor Antagonists [MoA]", "Nonsteroidal Mineralocorticoid-Receptor Antagonist [EPC]"], "product_ndc": "50419-540", "generic_name": "finerenone", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kerendia", "active_ingredients": [{"name": "FINERENONE", "strength": "10 mg/1"}], "application_number": "NDA215341", "marketing_category": "NDA", "marketing_start_date": "20210709", "listing_expiration_date": "20261231"}