Eplerenone

Product NDC
66993-343
11-digit product format
669930343
Labeler code
66993
Product ID
66993-343_523d18b8-4a66-4bd8-a6ab-f4dec2564d39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eplerenone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Prasco Laboratories
Application
ANDA203896
Marketing category
ANDA
Marketing start
2021-06-01
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
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66993-343DDiscontinued by firm2026-10-16
excluded packagepackage66993-34366993-343-30DDiscontinued by firm2026-10-16
excluded packagepackage66993-34366993-343-85DDiscontinued by firm2026-10-16

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 · 6 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 packagepackage66993-343-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66993-343-85d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66993-343-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66993-343-85f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A203896-001EPLERENONEEPLERENONE25MGTABLET / ORAL2017-02-02
A203896-002EPLERENONEEPLERENONE50MGTABLET / ORAL2017-02-02

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A203896-001EPLERENONE25MGTABLET / ORAL2017-02-02c2088c7a36db…
2026-10-15 13:18:302026-09A203896-002EPLERENONE50MGTABLET / ORAL2017-02-02c2088c7a36db…
2026-09-14 22:38:342026-08A203896-001EPLERENONE25MGTABLET / ORAL2017-02-0284e616aacf4f…
2026-09-14 22:38:342026-08A203896-002EPLERENONE50MGTABLET / ORAL2017-02-0284e616aacf4f…
2026-08-18 06:07:402026-07A203896-001EPLERENONE25MGTABLET / ORAL2017-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07A203896-002EPLERENONE50MGTABLET / ORAL2017-02-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203896-001EPLERENONE25MGTABLET / ORAL2017-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203896-002EPLERENONE50MGTABLET / ORAL2017-02-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203896-001EPLERENONE25MGTABLET / ORAL2017-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203896-002EPLERENONE50MGTABLET / ORAL2017-02-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203896-001EPLERENONE25MGTABLET / ORAL2017-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203896-002EPLERENONE50MGTABLET / ORAL2017-02-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203896-001EPLERENONE25MGTABLET / ORAL2017-02-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203896-002EPLERENONE50MGTABLET / ORAL2017-02-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203896-001EPLERENONE25MGTABLET / ORAL2017-02-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203896-002EPLERENONE50MGTABLET / ORAL2017-02-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203896-001EPLERENONE25MGTABLET / ORAL2017-02-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203896-002EPLERENONE50MGTABLET / ORAL2017-02-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203896-001EPLERENONE25MGTABLET / ORAL2017-02-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203896-002EPLERENONE50MGTABLET / ORAL2017-02-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203896-001EPLERENONE25MGTABLET / ORAL2017-02-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203896-002EPLERENONE50MGTABLET / ORAL2017-02-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203896-001EPLERENONE25MGTABLET / ORAL2017-02-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203896-002EPLERENONE50MGTABLET / ORAL2017-02-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203896-001EPLERENONE25MGTABLET / ORAL2017-02-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A203896-002EPLERENONE50MGTABLET / ORAL2017-02-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203896-001EPLERENONE25MGTABLET / ORAL2017-02-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203896-002EPLERENONE50MGTABLET / ORAL2017-02-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203896-001EPLERENONE25MGTABLET / ORAL2017-02-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203896-002EPLERENONE50MGTABLET / ORAL2017-02-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203896-001EPLERENONE25MGTABLET / ORAL2017-02-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203896-002EPLERENONE50MGTABLET / ORAL2017-02-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203896-001EPLERENONE25MGTABLET / ORAL2017-02-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203896-002EPLERENONE50MGTABLET / ORAL2017-02-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203896-001EPLERENONE25MGTABLET / ORALAB2017-02-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203896-002EPLERENONE50MGTABLET / ORALAB2017-02-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203896-001EPLERENONE25MGTABLET / ORALAB2017-02-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203896-002EPLERENONE50MGTABLET / ORALAB2017-02-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203896-001EPLERENONE25MGTABLET / ORALAB2017-02-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203896-002EPLERENONE50MGTABLET / ORALAB2017-02-024b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-05-13 08:27 UTC2023-05A203896-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A203896-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203896-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A203896-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203896-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203896-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203896-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A203896-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203896-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A203896-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203896-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203896-002AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-343-30EA - Each66993-3434e8ae184-b8a0-423f-8933-b23a2032c74212021-09-07
66993-343-85EA - Each66993-34328a280da-17f0-4249-a455-2c6c3144aa8512021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-343EPLERENONE TABLET, FILM COATED [PRASCO LABORATORIES]6Legacy NDC20250514_a4f0eb8e-39d8-4b30-8d96-4a017f42efec.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66993-343-306699303433030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-343-30) 2021-06-010000-00-00NoNoCurrent
66993-343-856699303438590 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-343-85) 2021-06-010000-00-00NoNoCurrent