Eplerenone

Product NDC
60505-2652
11-digit product format
605052652
Labeler code
60505
Product ID
60505-2652_22950bd8-01e9-7a46-48ce-abdc559ab833
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eplerenone
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp
Application
ANDA078482
Marketing category
ANDA
Marketing start
2008-07-30
Marketing end
0000-00-00
Substance
EPLERENONE
Active strength
50 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60505-2652DDiscontinued by firm2026-08-17
excluded packagepackage60505-265260505-2652-3DDiscontinued by firm2026-08-17
excluded packagepackage60505-265260505-2652-7DDiscontinued by firm2026-08-17
excluded packagepackage60505-265260505-2652-8DDiscontinued by firm2026-08-17
excluded packagepackage60505-265260505-2652-9DDiscontinued by firm2026-08-17

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 · 60 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 packagepackage60505-2652-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60505-2652-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60505-2652-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60505-2652-7d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60505-2652-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60505-2652-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60505-2652-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60505-2652-7f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60505-2652-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60505-2652-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60505-2652-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60505-2652-72ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60505-2652-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60505-2652-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60505-2652-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60505-2652-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60505-2652-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60505-2652-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60505-2652-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60505-2652-7cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60505-2652-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60505-2652-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60505-2652-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60505-2652-7cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60505-2652-8302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60505-2652-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60505-2652-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60505-2652-7302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60505-2652-8ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60505-2652-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60505-2652-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60505-2652-7ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60505-2652-80efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60505-2652-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60505-2652-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60505-2652-70efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60505-2652-8ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60505-2652-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60505-2652-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60505-2652-7ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60505-2652-8367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60505-2652-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60505-2652-9367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60505-2652-7367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60505-2652-8557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60505-2652-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60505-2652-9557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60505-2652-7557ba5c1ecfa…9c80585c8c6e…

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
A078482-001EPLERENONEEPLERENONE25MGTABLET / ORALAB2008-07-30
A078482-002EPLERENONEEPLERENONE50MGTABLET / ORALAB2008-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078482-001AB
A078482-002AB

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 06:07:402026-07A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078482-001EPLERENONE25MGTABLET / ORALAB2008-07-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078482-002EPLERENONE50MGTABLET / ORALAB2008-07-30bb7c543d1eb4…

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 06:07:402026-07A078482-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078482-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078482-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078482-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078482-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078482-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078482-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078482-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078482-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078482-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078482-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078482-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078482-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078482-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078482-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078482-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078482-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078482-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078482-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078482-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078482-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078482-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078482-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078482-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078482-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078482-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078482-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078482-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078482-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078482-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078482-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078482-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078482-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078482-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078482-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078482-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078482-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078482-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078482-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078482-002AB1bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2652-3EA - Each60505-2652a3824ff6-753f-48aa-9982-3f86c36c774e12013-05-02
60505-2652-9EA - Each60505-2652e3856f95-9349-48f3-ad6b-7e1f76417af112013-05-02