Eplerenone

Product NDC: 42291-454
Requested package NDC: 42291-454-30
11-digit product format: 422910454
Labeler code: 42291
Product ID: 42291-454_485d3fe4-eadd-a4dc-e063-6294a90ab9f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eplerenone
Dosage form: TABLET, COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA207842
Marketing category: ANDA
Marketing start: 2022-03-03
Substance: EPLERENONE
Active strength: 25 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42291-454	42291-454-30	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207842-001	EPLERENONE	EPLERENONE	25MG	TABLET / ORAL	AB		2021-10-25
A207842-002	EPLERENONE	EPLERENONE	50MG	TABLET / ORAL	AB		2021-10-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207842-001	AB
A207842-002	AB

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 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207842-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207842-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207842-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207842-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207842-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207842-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207842-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207842-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207842-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207842-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207842-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207842-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207842-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207842-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207842-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207842-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207842-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207842-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207842-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207842-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207842-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207842-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207842-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207842-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207842-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207842-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207842-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207842-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207842-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207842-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207842-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207842-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207842-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207842-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207842-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207842-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207842-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207842-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207842-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207842-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EPLERENONE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6995V82D0B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351256	Internal RxNorm lookup
351257	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
d953457e-0aff-6c38-e053-2995a90a7d32	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c046e2c-42d6-3179-f149-f207119f6ad5	Product name	6	20240530

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-454-30	Eplerenone	30 in 1 BOTTLE	TABLET, COATED	30		4
42291-454-90	Eplerenone	90 in 1 BOTTLE	TABLET, COATED	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-454-30	EA - Each	42291-454	291a477f-750c-4ea9-b1df-e8bc291a8b02	1	2022-09-12
42291-454-90	EA - Each	42291-454	6972fd4e-d10f-409f-b487-b65255cca324	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-454	EPLERENONE TABLET, COATED [AVKARE]	3	Current NDC, Legacy NDC, 2 package rows	20240110_d953457e-0aff-6c38-e053-2995a90a7d32.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eplerenone	EPLERENONE	AvKARE	d953457e-0aff-6c38-e053-2995a90a7d32	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207842 application number: ANDA207842 ndc (package): 42291-454-30 ndc (product): 42291-454 ndc11 (package): 42291045430
Eplerenone	EPLERENONE	Bryant Ranch Prepack	2002cf90-2d4a-43b1-bcd6-c447cbc7010f	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207842 application number: ANDA207842
Eplerenone	EPLERENONE	Proficient Rx LP	49b9759a-c1b9-4ebe-874b-81fb82a42755	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207842 application number: ANDA207842
Eplerenone	EPLERENONE	Westminster Pharmaceuticals, LLC	316d3a98-4cd1-4499-a34c-cac87e016944	2021-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207842 application number: ANDA207842

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6995V82D0B	EPLERENONE	107724-20-9	EPLERENONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351256	eplerenone 25 MG Oral Tablet	PSN	d953457e-0aff-6c38-e053-2995a90a7d32	4
351257	eplerenone 50 MG Oral Tablet	PSN	d953457e-0aff-6c38-e053-2995a90a7d32	4
351256	eplerenone 25 MG Oral Tablet	SCD	d953457e-0aff-6c38-e053-2995a90a7d32	4
351257	eplerenone 50 MG Oral Tablet	SCD	d953457e-0aff-6c38-e053-2995a90a7d32	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-454-30	42291045430	30 TABLET, COATED in 1 BOTTLE (42291-454-30)	2022-08-02	0000-00-00	No	No	Current