Eplerenone

Product NDC
73320-004
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct73320-004DDiscontinued by firm2026-08-10
excluded packagepackage73320-00473320-004-01DDiscontinued by firm2026-08-10
excluded packagepackage73320-00473320-004-06DDiscontinued by firm2026-08-10
excluded packagepackage73320-00473320-004-07DDiscontinued by firm2026-08-10

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 · 48 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 packagepackage73320-004-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73320-004-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73320-004-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73320-004-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73320-004-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73320-004-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73320-004-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73320-004-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73320-004-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73320-004-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73320-004-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73320-004-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73320-004-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73320-004-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73320-004-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73320-004-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73320-004-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73320-004-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73320-004-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73320-004-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73320-004-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73320-004-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73320-004-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73320-004-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73320-004-070efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73320-004-060efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73320-004-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73320-004-07ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73320-004-06ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73320-004-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73320-004-07367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73320-004-06367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73320-004-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73320-004-07557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73320-004-06557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73320-004-01557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214663-001EPLERENONEEPLERENONE25MGTABLET / ORALAB2022-03-23
A214663-002EPLERENONEEPLERENONE50MGTABLET / ORALAB2022-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214663-001AB
A214663-002AB

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 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-235d02ea3f76ae…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-236a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-231c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-23ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214663-001EPLERENONE25MGTABLET / ORALAB2022-03-23a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214663-002EPLERENONE50MGTABLET / ORALAB2022-03-23a72a2bbeb626…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214663-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214663-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214663-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214663-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214663-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214663-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214663-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214663-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214663-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214663-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214663-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214663-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214663-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214663-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214663-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214663-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214663-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214663-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214663-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214663-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214663-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214663-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214663-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214663-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214663-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214663-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214663-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214663-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214663-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214663-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214663-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214663-002AB15d02ea3f76ae…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214663-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214663-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214663-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214663-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214663-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214663-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214663-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214663-002AB1a72a2bbeb626…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
73320-004-012024-02-22These 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
73320-004-062024-02-22These 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
73320-004-072024-02-22These 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
73320-004-012024-01-30These 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
73320-004-062024-01-30These 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
73320-004-072024-01-30These 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EplerenoneEPLERENONERising Pharma Holdings, Inc.9b66a393-8af1-42bc-9673-89fe471147ee2025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214663
application number: ANDA214663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73320-004-017332000040130 TABLET, FILM COATED in 1 BOTTLE (73320-004-01) 2022-07-010000-00-00NoNoCurrent
73320-004-067332000040690 TABLET, FILM COATED in 1 BOTTLE (73320-004-06) 2022-07-010000-00-00NoNoCurrent
73320-004-077332000040710 BLISTER PACK in 1 CARTON (73320-004-07) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2022-07-010000-00-00NoNoCurrent