Inspra

Product NDC
58151-143
11-digit product format
581510143
Labeler code
58151
Product ID
58151-143_77698b88-befe-44ae-b67d-03c56dcbbdf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eplerenone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA021437
Marketing category
NDA
Marketing start
2024-09-17
Marketing end
2027-01-31
Substance
EPLERENONE
Active strength
50 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
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
Inspra

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPLERENONE50 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
351256Internal RxNorm lookup
351257Internal RxNorm lookup
402105Internal RxNorm lookup
402106Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a52bedc-8e2c-4116-a296-a87770676b4aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c046e2c-42d6-3179-f149-f207119f6ad5Product name620240530
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58151-143-93Inspra30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-143-93EA - Each58151-1437bdea7fc-4830-4db9-a7c5-aff43f687b3512024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-143INSPRA (EPLERENONE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC]2Current NDC, 1 package rows20240919_1a52bedc-8e2c-4116-a296-a87770676b4a.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
ndc (product): 58151-143
EplerenoneEPLERENONEMylan Pharmaceuticals Inc.4286699b-2320-4d3d-831c-32085f36fb672025-06-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021437
application number: NDA021437
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 TabletPSN1a52bedc-8e2c-4116-a296-a87770676b4a6
351257eplerenone 50 MG Oral TabletPSN1a52bedc-8e2c-4116-a296-a87770676b4a6
402106INSPRA 25 MG Oral TabletPSN1a52bedc-8e2c-4116-a296-a87770676b4a6
402105INSPRA 50 MG Oral TabletPSN1a52bedc-8e2c-4116-a296-a87770676b4a6
402106eplerenone 25 MG Oral Tablet [Inspra]SBD1a52bedc-8e2c-4116-a296-a87770676b4a6
402105eplerenone 50 MG Oral Tablet [Inspra]SBD1a52bedc-8e2c-4116-a296-a87770676b4a6
351256eplerenone 25 MG Oral TabletSCD1a52bedc-8e2c-4116-a296-a87770676b4a6
351257eplerenone 50 MG Oral TabletSCD1a52bedc-8e2c-4116-a296-a87770676b4a6
402106Inspra 25 MG Oral TabletSY1a52bedc-8e2c-4116-a296-a87770676b4a6
402105Inspra 50 MG Oral TabletSY1a52bedc-8e2c-4116-a296-a87770676b4a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58151-143-935815101439330 TABLET, FILM COATED in 1 BOTTLE (58151-143-93) 2024-09-172027-01-31NoNoHistorical