Eplerenone

Product NDC
42254-011
11-digit product format
422540011
Labeler code
42254
Product ID
42254-011_4743a48b-d4b5-4054-85e1-9d64cc40de25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eplerenone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA078510
Marketing category
ANDA
Marketing start
2008-08-01
Marketing end
0000-00-00
Substance
EPLERENONE
Active strength
50 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42254-011IInactivated by FDA2026-08-17
excluded packagepackage42254-01142254-011-90IInactivated by FDA2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42254-011-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42254-011-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42254-011-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42254-011-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42254-011-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42254-011-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42254-011-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42254-011-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42254-011-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42254-011-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42254-011-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42254-011-90557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42254-011-908af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42254-011-90834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42254-011-901332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42254-011-90fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42254-011-9086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42254-011-90bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42254-011-908dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42254-011-90e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42254-011-909bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42254-011-90110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078510-001EPLERENONEEPLERENONE25MGTABLET / ORALAB2008-08-01
A078510-002EPLERENONEEPLERENONE50MGTABLET / ORALAB2008-08-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078510-001AB
A078510-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-01caaa826d4ba7…
2026-08-18 06:07:402026-07A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078510-001EPLERENONE25MGTABLET / ORALAB2008-08-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078510-002EPLERENONE50MGTABLET / ORALAB2008-08-01bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078510-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078510-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078510-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078510-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078510-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078510-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078510-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078510-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078510-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078510-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078510-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078510-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078510-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078510-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078510-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078510-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078510-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078510-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078510-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078510-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078510-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078510-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078510-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078510-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078510-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078510-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078510-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078510-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078510-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078510-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078510-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078510-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078510-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078510-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078510-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078510-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078510-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078510-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078510-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078510-002AB1bb7c543d1eb4…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c046e2c-42d6-3179-f149-f207119f6ad5Product name620240530

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-011-90Eplerenone90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-011-90EA - Each42254-0112f73f1ff-94a9-43c0-ba84-94b83710704912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPLERENONEACTIVE INGREDIENT6995V82D0BEPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1
EPLERENONEACTIVE MOIETY6995V82D0BEPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MEPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GEPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEEPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UEPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-011EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20111118_4743a48b-d4b5-4054-85e1-9d64cc40de25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351257eplerenone 50 MG Oral TabletPSN4743a48b-d4b5-4054-85e1-9d64cc40de251
351257eplerenone 50 MG Oral TabletSCD4743a48b-d4b5-4054-85e1-9d64cc40de251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-011-904225400119090 in 1 BOTTLEHistorical