Eplerenone

Product NDC: 73320-004
Requested package NDC: 73320-004-01
11-digit product format: 733200004
Labeler code: 73320
Product ID: 73320-004_f925bd40-9c6b-425c-94c5-6e762823e56b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eplerenone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Kartha Pharmaceuticals, Inc.
Application: ANDA214663
Marketing category: ANDA
Marketing start: 2022-07-01
Marketing end: 0000-00-00
Substance: EPLERENONE
Active strength: 25 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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	73320-004	73320-004-01	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A214663-001	EPLERENONE	EPLERENONE	25MG	TABLET / ORAL	AB		2022-03-23
A214663-002	EPLERENONE	EPLERENONE	50MG	TABLET / ORAL	AB		2022-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214663-001	AB
A214663-002	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 · 60 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
2026-02-19 14:30 UTC	2026-02	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214663-001	EPLERENONE	25MG	TABLET / ORAL	AB	2022-03-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214663-002	EPLERENONE	50MG	TABLET / ORAL	AB	2022-03-23	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214663-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214663-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214663-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214663-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214663-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214663-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214663-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214663-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214663-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214663-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214663-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214663-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214663-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214663-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214663-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214663-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214663-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214663-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214663-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214663-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214663-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214663-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214663-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214663-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214663-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214663-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214663-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214663-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214663-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214663-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214663-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214663-002	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214663-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214663-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214663-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214663-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214663-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214663-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214663-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214663-002	AB	1	`a72a2bbeb626…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
73320-004-01	2024-02-22	These highlights do not include all the information needed to use EPLERENONE TABLETS safely and effectively. See full prescribing information for EPLERENONE TABLETS. Eplerenone tablets, for oral use Initial U.S. Approval: 2002
73320-004-06	2024-02-22	These highlights do not include all the information needed to use EPLERENONE TABLETS safely and effectively. See full prescribing information for EPLERENONE TABLETS. Eplerenone tablets, for oral use Initial U.S. Approval: 2002
73320-004-07	2024-02-22	These highlights do not include all the information needed to use EPLERENONE TABLETS safely and effectively. See full prescribing information for EPLERENONE TABLETS. Eplerenone tablets, for oral use Initial U.S. Approval: 2002
73320-004-01	2024-01-30	These highlights do not include all the information needed to use EPLERENONE TABLETS safely and effectively. See full prescribing information for EPLERENONE TABLETS. Eplerenone tablets, for oral use Initial U.S. Approval: 2002
73320-004-06	2024-01-30	These highlights do not include all the information needed to use EPLERENONE TABLETS safely and effectively. See full prescribing information for EPLERENONE TABLETS. Eplerenone tablets, for oral use Initial U.S. Approval: 2002
73320-004-07	2024-01-30	These highlights do not include all the information needed to use EPLERENONE TABLETS safely and effectively. See full prescribing information for EPLERENONE TABLETS. Eplerenone tablets, for oral use Initial U.S. Approval: 2002

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
Eplerenone	EPLERENONE	Rising Pharma Holdings, Inc.	9b66a393-8af1-42bc-9673-89fe471147ee	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214663 application number: ANDA214663

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
73320-004-01	73320000401	30 TABLET, FILM COATED in 1 BOTTLE (73320-004-01)	2022-07-01	0000-00-00	No	No	Current