SPIRONOLACTONE

Product NDC
59651-426
11-digit product format
596510426
Labeler code
59651
Product ID
59651-426_9b6802a0-5117-4be3-a113-9098e8dcedaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202187
Marketing category
ANDA
Marketing start
2019-12-13
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202187-001SPIRONOLACTONESPIRONOLACTONE25MGTABLET / ORALAB2014-03-06
A202187-002SPIRONOLACTONESPIRONOLACTONE50MGTABLET / ORALAB2014-03-06
A202187-003SPIRONOLACTONESPIRONOLACTONE100MGTABLET / ORALAB2014-03-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202187-001AB
A202187-002AB
A202187-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202187-002SPIRONOLACTONE50MGTABLET / ORALAB2014-03-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202187-003SPIRONOLACTONE100MGTABLET / ORALAB2014-03-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202187-001SPIRONOLACTONE25MGTABLET / ORALAB2014-03-068072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202187-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202187-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202187-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202187-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202187-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202187-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202187-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202187-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202187-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202187-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202187-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202187-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202187-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202187-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202187-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202187-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202187-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202187-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202187-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202187-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202187-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202187-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202187-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202187-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202187-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202187-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202187-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202187-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202187-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202187-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202187-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202187-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202187-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202187-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202187-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202187-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202187-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202187-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202187-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202187-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
SPIRONOLACTONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIRONOLACTONE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
27O7W4T232Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198222Internal RxNorm lookup
198223Internal RxNorm lookup
313096Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
768563dc-a619-44dc-b97f-1a7e71fd56a0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d335cba1-5b36-51c8-120a-594ec9d05330Product name520251114
25f5e2cf-3572-477b-994c-aa692751e5a8Product name220250616
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-426-01SPIRONOLACTONE100 in 1 BOTTLETABLET1008
59651-426-05SPIRONOLACTONE500 in 1 BOTTLETABLET5008
59651-426-99SPIRONOLACTONE1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-426-01EA - Each59651-4267f61e096-e79f-4cdb-87fd-18d53c02d2c412023-01-09
59651-426-05EA - Each59651-426b7445534-0fb5-45ee-8579-bdc3ba2b202512023-01-09
59651-426-99EA - Each59651-426736431d8-3c1a-460f-90e6-6647a7c8a45112023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-426SPIRONOLACTONE TABLET [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 3 package rows20230829_768563dc-a619-44dc-b97f-1a7e71fd56a0.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPIRONOLACTONESPIRONOLACTONERedpharm Drug57d1c333-c229-54aa-e063-6394a90a84ce2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187
SPIRONOLACTONESPIRONOLACTONENorthStar Rx LLCae0dcb4e-63df-459c-8e60-0caa817b81352026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187
SPIRONOLACTONESPIRONOLACTONEAurobindo Pharma Limited768563dc-a619-44dc-b97f-1a7e71fd56a02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187
ndc (product): 59651-426
SPIRONOLACTONESPIRONOLACTONENuCare Pharmaceuticals,Inc.4239da9e-dd0c-9af0-e063-6394a90a3cbb2025-10-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187
SPIRONOLACTONESPIRONOLACTONEREMEDYREPACK INC.860b08bf-c6c1-4310-8510-10b6779f3d592025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187
SPIRONOLACTONESPIRONOLACTONENuCare Pharmaceuticals, Inc.2e5e782d-9ceb-d4a4-e063-6294a90aba3a2025-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187
SPIRONOLACTONESPIRONOLACTONENuCare Pharmaceuticals,Inc.f98cc3be-cf59-e3d2-e053-6294a90a2ae02025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187
SPIRONOLACTONESPIRONOLACTONENuCare Pharmaceuticals,Inc.f9b79b4a-1a48-6247-e053-6394a90a2ae12025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187
SPIRONOLACTONESPIRONOLACTONEA-S Medication Solutionsa73e3dd9-4958-4a2c-853f-45b2810b16392024-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187
SPIRONOLACTONESPIRONOLACTONENCS HealthCare of KY, LLC dba Vangard Labse34fc3ca-1272-446b-8dc2-25b62add01c32024-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187
SPIRONOLACTONESPIRONOLACTONEA-S Medication Solutions781e0f31-a7c8-4a05-bb38-88f6dd8747462024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187
SPIRONOLACTONESPIRONOLACTONEA-S Medication Solutions985524c3-9fb3-4874-9eb6-80b17af3d8ed2023-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187
SPIRONOLACTONESPIRONOLACTONEA-S Medication Solutions7ef0c2bb-9657-419e-848c-858893be50bc2023-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202187
application number: ANDA202187

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSN768563dc-a619-44dc-b97f-1a7e71fd56a08
313096spironolactone 25 MG Oral TabletPSN768563dc-a619-44dc-b97f-1a7e71fd56a08
313096spironolactone 25 MG Oral TabletPSNe34fc3ca-1272-446b-8dc2-25b62add01c38
198223spironolactone 50 MG Oral TabletPSN768563dc-a619-44dc-b97f-1a7e71fd56a08
198223spironolactone 50 MG Oral TabletPSNe34fc3ca-1272-446b-8dc2-25b62add01c38
198222spironolactone 100 MG Oral TabletSCD768563dc-a619-44dc-b97f-1a7e71fd56a08
313096spironolactone 25 MG Oral TabletSCD768563dc-a619-44dc-b97f-1a7e71fd56a08
313096spironolactone 25 MG Oral TabletSCDe34fc3ca-1272-446b-8dc2-25b62add01c38
198223spironolactone 50 MG Oral TabletSCD768563dc-a619-44dc-b97f-1a7e71fd56a08
198223spironolactone 50 MG Oral TabletSCDe34fc3ca-1272-446b-8dc2-25b62add01c38
313096spironolactone 25 MG Oral TabletPSNf9b79b4a-1a48-6247-e053-6394a90a2ae13
313096spironolactone 25 MG Oral TabletSCDf9b79b4a-1a48-6247-e053-6394a90a2ae13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-426-0159651042601100 TABLET in 1 BOTTLE (59651-426-01) 100 tablet2019-12-130000-00-00NoNoCurrent
59651-426-0559651042605500 TABLET in 1 BOTTLE (59651-426-05) 500 tablet2019-12-130000-00-00NoNoCurrent
59651-426-99596510426991000 TABLET in 1 BOTTLE (59651-426-99) 1000 tablet2019-12-130000-00-00NoNoCurrent