Home NDC 50419-541 Kerendia
Product NDC 50419-541
11-digit product format 504190541
Labeler code 50419
Product ID 50419-541_28aa9af2-2939-46e0-8c9c-af939e81b551
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name finerenone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bayer HealthCare Pharmaceuticals Inc.
Application NDA215341
Marketing category NDA
Marketing start 2021-07-09
Substance FINERENONE
Active strength 20 mg/1
Pharmacologic classes Mineralocorticoid Receptor Antagonists [MoA], Nonsteroidal Mineralocorticoid-Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215341-001 KERENDIA FINERENONE 10MG TABLET / ORAL RLD 2021-07-09 N215341-002 KERENDIA FINERENONE 20MG TABLET / ORAL RLD 2021-07-09 N215341-003 KERENDIA FINERENONE 40MG TABLET / ORAL RLD, RS 2025-07-11
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215341-001 8436180 2033-08-26 Drug substance, Drug product 2021-08-06 N215341-001 RE49826 2035-07-29 Drug substance 2024-03-01 N215341-002 8436180 2033-08-26 Drug substance, Drug product 2021-08-06 N215341-002 RE49826 2035-07-29 Drug substance 2024-03-01 N215341-003 8436180 2033-08-26 Drug substance, Drug product 2025-07-25 N215341-003 RE49826 2035-07-29 Drug substance 2025-07-25
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 70 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215341-003 KERENDIA 40MG TABLET / ORAL RLD 2025-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215341-003 KERENDIA 40MG TABLET / ORAL RLD 2025-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215341-003 KERENDIA 40MG TABLET / ORAL RLD 2025-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N215341-002 KERENDIA 20MG TABLET / ORAL RLD, RS 2021-07-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N215341-001 KERENDIA 10MG TABLET / ORAL RLD 2021-07-09 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 3 · 106 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215341-001 8436180 2033-08-26 Drug substance, Drug product 2021-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215341-001 RE49826 2035-07-29 Drug substance 2024-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215341-002 8436180 2033-08-26 Drug substance, Drug product 2021-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215341-002 RE49826 2035-07-29 Drug substance 2024-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215341-003 8436180 2033-08-26 Drug substance, Drug product 2025-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215341-003 RE49826 2035-07-29 Drug substance 2025-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215341-001 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215341-001 RE49826 2035-07-29 Drug substance 2024-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215341-002 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215341-002 RE49826 2035-07-29 Drug substance 2024-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215341-003 8436180 2029-04-12 Drug substance, Drug product 2025-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215341-003 RE49826 2035-07-29 Drug substance 2025-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215341-001 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215341-001 RE49826 2035-07-29 Drug substance 2024-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215341-002 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215341-002 RE49826 2035-07-29 Drug substance 2024-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215341-003 8436180 2029-04-12 Drug substance, Drug product 2025-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215341-003 RE49826 2035-07-29 Drug substance 2025-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215341-001 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215341-001 RE49826 2035-07-29 Drug substance 2024-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215341-002 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215341-002 RE49826 2035-07-29 Drug substance 2024-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215341-001 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215341-001 RE49826 2035-07-29 Drug substance 2024-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215341-002 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215341-002 RE49826 2035-07-29 Drug substance 2024-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215341-001 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215341-001 RE49826 2035-07-29 Drug substance 2024-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215341-002 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215341-002 RE49826 2035-07-29 Drug substance 2024-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215341-001 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215341-001 RE49826 2035-07-29 Drug substance 2024-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215341-002 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215341-002 RE49826 2035-07-29 Drug substance 2024-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215341-001 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215341-001 RE49826 2035-07-29 Drug substance 2024-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215341-002 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215341-002 RE49826 2035-07-29 Drug substance 2024-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215341-001 8436180 2029-04-12 Drug substance, Drug product 2021-08-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215341-001 RE49826 2035-07-29 Drug substance 2024-03-01 d8e5a09893c0…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 130 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Kerendia
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FINERENONE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DE2O63YV8R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2562816 Internal RxNorm lookup 2562822 Internal RxNorm lookup 2562824 Internal RxNorm lookup 2562826 Internal RxNorm lookup 2720069 Internal RxNorm lookup 2720071 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50419-541-01 Kerendia 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 13 50419-541-02 Kerendia 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 13 50419-541-06 Kerendia 10 in 1 BLISTER PACK TABLET, FILM COATED 10 13 50419-541-70 Kerendia 7 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 7 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-541 KERENDIA (FINERENONE) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 Current NDC, Legacy NDC, 4 package rows 20240716_fc726765-5d5a-4d6e-b037-b847bda9fb7c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50419-541-01 50419054101 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-541-01) 2021-07-09 0000-00-00 No No Current 50419-541-02 50419054102 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-541-02) 2021-07-09 0000-00-00 No No Current 50419-541-06 50419054106 10 TABLET, FILM COATED in 1 BLISTER PACK (50419-541-06) 2025-08-23 No No Current 50419-541-70 50419054170 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-541-70) 2021-07-09 0000-00-00 No No Current