Kerendia

Product NDC: 50419-542
11-digit product format: 504190542
Labeler code: 50419
Product ID: 50419-542_28aa9af2-2939-46e0-8c9c-af939e81b551
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: finerenone
Dosage form: TABLET
Route: ORAL
Labeler: Bayer HealthCare Pharmaceuticals Inc.
Application: NDA215341
Marketing category: NDA
Marketing start: 2021-07-09
Substance: FINERENONE
Active strength: 40 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	50419-542		UNFINISHED	Active or certified unfinished drug listing		2026-08-07
unfinished package	package	50419-542	50419-542-05	UNFINISHED	Active or certified unfinished drug listing		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	50419-542-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	50419-542-05	`1d862106b807…`	`00c93037cd84…`

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	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	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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215341-001	NCE	2026-07-09
N215341-001	I-970	2028-07-11
N215341-002	NCE	2026-07-09
N215341-002	I-970	2028-07-11
N215341-003	NCE	2026-07-09
N215341-003	NS	2028-07-11

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	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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215341-001	NCE	2026-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-001	I-970	2028-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-002	NCE	2026-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-002	I-970	2028-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-003	NCE	2026-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-003	NS	2028-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	M-279	2025-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	NCE	2026-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	I-970	2028-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	M-279	2025-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	NCE	2026-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	I-970	2028-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-003	NCE	2026-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-003	NS	2028-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215341-001	M-279	2025-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-001	NCE	2026-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-001	I-970	2028-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	M-279	2025-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	NCE	2026-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	I-970	2028-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-003	NCE	2026-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-003	NS	2028-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-001	M-279	2025-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-001	NCE	2026-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-002	M-279	2025-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-002	NCE	2026-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-001	M-279	2025-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-001	NCE	2026-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-002	M-279	2025-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-002	NCE	2026-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-001	M-279	2025-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-001	NCE	2026-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-002	M-279	2025-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-002	NCE	2026-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-001	M-279	2025-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-001	NCE	2026-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-002	M-279	2025-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-002	NCE	2026-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215341-001	M-279	2025-09-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215341-001	NCE	2026-07-09	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Kerendia
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FINERENONE	40 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fc726765-5d5a-4d6e-b037-b847bda9fb7c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa46b598-c230-45e9-929b-261545cf6b50	Product name	1	20220125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50419-542-01	Kerendia	30 in 1 BOTTLE, PLASTIC	TABLET	30	13
50419-542-02	Kerendia	90 in 1 BOTTLE, PLASTIC	TABLET	90	13
50419-542-06	Kerendia	10 in 1 BLISTER PACK	TABLET	10	13
50419-542-70	Kerendia	7 in 1 BOTTLE, PLASTIC	TABLET	7	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-542-01	EA - Each	50419-542	f2ceddfc-2f95-423c-99db-0f5d989b6aae	1	2025-08-11
50419-542-02	EA - Each	50419-542	57c8d14c-4ca8-4eff-99d6-12903a2ec9b4	1	2025-08-11
50419-542-05	EA - Each	50419-542	0d729f27-a81d-4068-bfe6-deabe23d7be1	1	2025-08-11
50419-542-06	EA - Each	50419-542	5495cad8-b457-4516-9101-005288d1aa04	1	2025-08-11

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kerendia	FINERENONE	Bayer HealthCare Pharmaceuticals Inc.	fc726765-5d5a-4d6e-b037-b847bda9fb7c	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215341 application number: NDA215341 ndc (product): 50419-542

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DE2O63YV8R	FINERENONE	1050477-31-0	FINERENONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2562816	finerenone 10 MG Oral Tablet	PSN	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2562824	finerenone 20 MG Oral Tablet	PSN	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2720069	finerenone 40 MG Oral Tablet	PSN	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2562822	Kerendia 10 MG Oral Tablet	PSN	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2562826	Kerendia 20 MG Oral Tablet	PSN	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2720071	Kerendia 40 MG Oral Tablet	PSN	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2562822	finerenone 10 MG Oral Tablet [Kerendia]	SBD	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2562826	finerenone 20 MG Oral Tablet [Kerendia]	SBD	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2720071	finerenone 40 MG Oral Tablet [Kerendia]	SBD	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2562816	finerenone 10 MG Oral Tablet	SCD	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2562824	finerenone 20 MG Oral Tablet	SCD	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2720069	finerenone 40 MG Oral Tablet	SCD	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2562822	Kerendia 10 MG Oral Tablet	SY	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2562826	Kerendia 20 MG Oral Tablet	SY	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13
2720071	Kerendia 40 MG Oral Tablet	SY	fc726765-5d5a-4d6e-b037-b847bda9fb7c	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50419-542-01	50419054201	30 TABLET in 1 BOTTLE, PLASTIC (50419-542-01)	30 tablet	2025-07-11	No	No	Current
50419-542-02	50419054202	90 TABLET in 1 BOTTLE, PLASTIC (50419-542-02)	90 tablet	2025-07-11	No	No	Current
50419-542-05	50419054205	10 BLISTER PACK in 1 CARTON (50419-542-05) / 10 TABLET in 1 BLISTER PACK	10 blister pack	13-JUL-25			Current
50419-542-06	50419054206	10 TABLET in 1 BLISTER PACK (50419-542-06)	10 tablet	2025-07-11	No	No	Current
50419-542-70	50419054270	7 TABLET in 1 BOTTLE, PLASTIC (50419-542-70)	7 tablet	2025-07-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kerendia	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG \| Sharp Corporation \| AMPAC Fine Chemicals, Rancho Cordova \| Delpharm Milano Srl	2025-08-28	HUMAN PRESCRIPTION DRUG LABEL	13