eplerenone

Product NDC: 70436-098
11-digit product format: 704360098
Labeler code: 70436
Product ID: 70436-098_6514e849-b6de-4c32-bc36-0e3a5b431cee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: eplerenone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Slate Run Pharmaceuticals, LLC
Application: ANDA212765
Marketing category: ANDA
Marketing start: 2021-01-04
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: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70436-098		D	Discontinued by firm	2026-08-17
excluded package	package	70436-098	70436-098-01	D	Discontinued by firm	2026-08-17
excluded package	package	70436-098	70436-098-04	D	Discontinued by firm	2026-08-17
excluded package	package	70436-098	70436-098-06	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
A212765-001	EPLERENONE	EPLERENONE	25MG	TABLET / ORAL	AB		2020-08-10
A212765-002	EPLERENONE	EPLERENONE	50MG	TABLET / ORAL	AB		2020-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212765-001	AB
A212765-002	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 · 76 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	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212765-001	EPLERENONE	25MG	TABLET / ORAL		2020-08-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212765-002	EPLERENONE	50MG	TABLET / ORAL		2020-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212765-001	EPLERENONE	25MG	TABLET / ORAL		2020-08-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212765-002	EPLERENONE	50MG	TABLET / ORAL		2020-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212765-001	EPLERENONE	25MG	TABLET / ORAL		2020-08-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212765-002	EPLERENONE	50MG	TABLET / ORAL		2020-08-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212765-001	EPLERENONE	25MG	TABLET / ORAL		2020-08-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212765-002	EPLERENONE	50MG	TABLET / ORAL		2020-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212765-001	EPLERENONE	25MG	TABLET / ORAL		2020-08-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212765-002	EPLERENONE	50MG	TABLET / ORAL		2020-08-10	`782e0a99824c…`

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
2026-08-18 06:07:40	2026-07	A212765-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212765-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212765-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212765-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212765-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212765-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212765-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212765-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212765-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212765-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212765-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212765-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212765-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212765-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212765-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212765-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212765-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212765-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212765-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212765-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212765-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212765-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212765-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212765-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212765-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212765-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212765-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212765-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212765-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212765-002	AB	1	`8072bd15b7f6…`
2021-03-12 10:30 UTC	2021-03	A212765-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A212765-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212765-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A212765-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212765-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A212765-002	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212765-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212765-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212765-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212765-002	AB	1	`1c564ffb4f44…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70436-098	EPLERENONE TABLET, FILM COATED [SLATE RUN PHARMACEUTICALS, LLC]	1	Legacy NDC	20210104_6514e849-b6de-4c32-bc36-0e3a5b431cee.zip

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
70436-098-01	70436009801	100 TABLET, FILM COATED in 1 BOTTLE (70436-098-01)	2021-01-04	0000-00-00	No	No	Current
70436-098-04	70436009804	30 TABLET, FILM COATED in 1 BOTTLE (70436-098-04)	2021-01-04	0000-00-00	No	No	Current
70436-098-06	70436009806	90 TABLET, FILM COATED in 1 BOTTLE (70436-098-06)	2021-01-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
eplerenone	Slate Run Pharmaceuticals, LLC \| Piramal Healthcare UK Limited	2020-08-19	HUMAN PRESCRIPTION DRUG LABEL	1