Kerendia

Product NDC: 50419-542
Requested package NDC: 50419-542-70
11-digit product format: 504190542
Labeler code: 50419
Product ID: 50419-542_0be3a1c5-0088-43b1-b2f0-1faa1ea87c5b
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 9 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
N215341-001	I-998	2029-09-16
N215341-002	NCE	2026-07-09
N215341-002	I-970	2028-07-11
N215341-002	I-998	2029-09-16
N215341-003	NCE	2026-07-09
N215341-003	NS	2028-07-11
N215341-003	I-998	2029-09-16

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 · 79 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD	2021-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-003	KERENDIA	40MG	TABLET / ORAL	RLD, RS	2025-07-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD	2021-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-003	KERENDIA	40MG	TABLET / ORAL	RLD, RS	2025-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD	2021-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-003	KERENDIA	40MG	TABLET / ORAL	RLD, RS	2025-07-11	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215341-001	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-002	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-003	8436180	2033-08-26	Drug substance, Drug product	2025-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215341-001	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-002	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-003	8436180	2033-08-26	Drug substance, Drug product	2025-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215341-001	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-002	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-003	8436180	2033-08-26	Drug substance, Drug product	2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 151 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N215341-001	NCE	2026-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-001	I-970	2028-07-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-001	I-998	2029-09-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-002	NCE	2026-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-002	I-970	2028-07-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-002	I-998	2029-09-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-003	NCE	2026-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-003	NS	2028-07-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-003	I-998	2029-09-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215341-001	NCE	2026-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-001	I-970	2028-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-002	NCE	2026-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-002	I-970	2028-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-003	NCE	2026-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-003	NS	2028-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215341-001	NCE	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-001	I-970	2028-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-002	NCE	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-002	I-970	2028-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-003	NCE	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-003	NS	2028-07-11	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Kerendia
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FINERENONE	40 mg/1

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

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
50419-542-70	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	2026-09-21	HUMAN PRESCRIPTION DRUG LABEL	15