Eplerenone

Product NDC
59762-1107
11-digit product format
597621107
Labeler code
59762
Product ID
59762-1107_b4bf45ee-6524-4a9d-9d7d-91886e32ee72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eplerenone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA021437
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-12-13
Substance
EPLERENONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021437-001INSPRAEPLERENONE25MGTABLET / ORALABRLD2002-09-27
N021437-002INSPRAEPLERENONE50MGTABLET / ORALABRLD, RS2002-09-27
N021437-003INSPRAEPLERENONE100MGTABLET / ORAL2002-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021437-001AB
N021437-002AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27caaa826d4ba7…
2026-08-18 06:07:402026-07N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27caaa826d4ba7…
2026-08-18 06:07:402026-07N021437-003INSPRA100MGTABLET / ORAL2002-09-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021437-003INSPRA100MGTABLET / ORAL2002-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021437-003INSPRA100MGTABLET / ORAL2002-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021437-003INSPRA100MGTABLET / ORAL2002-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021437-003INSPRA100MGTABLET / ORAL2002-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021437-003INSPRA100MGTABLET / ORAL2002-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021437-003INSPRA100MGTABLET / ORAL2002-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021437-003INSPRA100MGTABLET / ORAL2002-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021437-003INSPRA100MGTABLET / ORAL2002-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021437-003INSPRA100MGTABLET / ORAL2002-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N021437-003INSPRA100MGTABLET / ORAL2002-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021437-003INSPRA100MGTABLET / ORAL2002-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021437-003INSPRA100MGTABLET / ORAL2002-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-271e350fbaab3a…

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 06:07:402026-07N021437-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021437-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021437-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021437-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021437-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021437-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021437-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021437-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021437-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021437-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021437-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021437-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021437-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021437-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021437-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021437-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021437-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021437-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021437-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021437-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021437-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021437-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021437-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021437-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021437-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021437-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021437-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021437-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021437-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021437-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021437-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021437-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021437-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021437-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021437-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021437-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021437-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021437-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021437-002AB1bb7c543d1eb4…

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021437-00164105242019-11-05U-46774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00167470202019-11-05U-58774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00164100542019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00164100542019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00164951652019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00164951652019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00165340932019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00165340932019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00165587072019-12-08U-537Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00171571012019-12-08U-664Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0016410524*PED2020-05-05Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0016747020*PED2020-05-05Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0016410054*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0016495165*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0016534093*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0016558707*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0017157101*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00264105242019-11-05U-46774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00267470202019-11-05U-58774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00264100542019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00264100542019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00264951652019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00264951652019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00265340932019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00265340932019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00265587072019-12-08U-537Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00271571012019-12-08U-664Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0026410524*PED2020-05-05Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0026747020*PED2020-05-05Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0026410054*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0026495165*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0026534093*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0026558707*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0027157101*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00364105242019-11-05U-46774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00367470202019-11-05U-58774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00364100542019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00364100542019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00364951652019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00364951652019-12-08U-53774a2ff9319b5…

Additional Listing Data#

Finished product
Yes
Brand name base
Eplerenone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPLERENONE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6995V82D0BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
351256Internal RxNorm lookup
351257Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4286699b-2320-4d3d-831c-32085f36fb67Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-1107-2Eplerenone30 in 1 BOTTLETABLET, FILM COATED3046
59762-1107-3Eplerenone90 in 1 BOTTLETABLET, FILM COATED9046

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1107-2EA - Each59762-11071100f87b-ea88-48bf-b14f-190895433a6a12025-01-14
59762-1107-3EA - Each59762-1107047a8b0c-a47d-40d8-95a7-e09a7dda4f6712025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1107EPLERENONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250503_4286699b-2320-4d3d-831c-32085f36fb67.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
InspraEPLERENONEViatris Specialty LLC1a52bedc-8e2c-4116-a296-a87770676b4a2025-06-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021437
application number: NDA021437
EplerenoneEPLERENONEMylan Pharmaceuticals Inc.4286699b-2320-4d3d-831c-32085f36fb672025-06-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021437
application number: NDA021437
ndc (product): 59762-1107
EplerenoneEPLERENONEMylan Pharmaceuticals Inc.6d988699-95c2-46b9-8266-23fe7016f33b2020-08-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 021437
application number: NDA021437

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351256eplerenone 25 MG Oral TabletPSN4286699b-2320-4d3d-831c-32085f36fb6746
351257eplerenone 50 MG Oral TabletPSN4286699b-2320-4d3d-831c-32085f36fb6746
351256eplerenone 25 MG Oral TabletSCD4286699b-2320-4d3d-831c-32085f36fb6746
351257eplerenone 50 MG Oral TabletSCD4286699b-2320-4d3d-831c-32085f36fb6746

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59762-1107-25976211070230 TABLET, FILM COATED in 1 BOTTLE (59762-1107-2) 2024-12-13NoNoCurrent
59762-1107-35976211070390 TABLET, FILM COATED in 1 BOTTLE (59762-1107-3) 2025-10-24NoNoCurrent