Spironolactone

Product NDC
76420-925
Requested package NDC
76420-925-01
11-digit product format
764200925
Labeler code
76420
Product ID
76420-925_2fa991e8-8594-6911-e063-6294a90a916d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA040750
Marketing category
ANDA
Marketing start
2021-01-04
Substance
SPIRONOLACTONE
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 43.

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
A040750-001SPIRONOLACTONESPIRONOLACTONE25MGTABLET / ORALAB2006-08-29
A040750-002SPIRONOLACTONESPIRONOLACTONE50MGTABLET / ORALAB2006-08-29
A040750-003SPIRONOLACTONESPIRONOLACTONE100MGTABLET / ORALAB2006-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040750-001AB
A040750-002AB
A040750-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-2984e616aacf4f…
2026-09-14 22:38:342026-08A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-2984e616aacf4f…
2026-09-14 22:38:342026-08A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-2984e616aacf4f…
2026-08-18 06:07:402026-07A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-29301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A040750-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A040750-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A040750-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A040750-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040750-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040750-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040750-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040750-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040750-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040750-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040750-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040750-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040750-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040750-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040750-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040750-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040750-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040750-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040750-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040750-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040750-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040750-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040750-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040750-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040750-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040750-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040750-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040750-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040750-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040750-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040750-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040750-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040750-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040750-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040750-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040750-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040750-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040750-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040750-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040750-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

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
db22e9e5-2d88-4712-a809-c00881edb447Available 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
76420-925-00Spironolactone1000 in 1 BOTTLETABLET, COATED10001
76420-925-01Spironolactone100 in 1 BOTTLETABLET, COATED1001
76420-925-05Spironolactone500 in 1 BOTTLETABLET, COATED5001
76420-925-25Spironolactone2500 in 1 BOTTLETABLET, COATED25001
76420-925-30Spironolactone30 in 1 BOTTLETABLET, COATED301
76420-925-60Spironolactone60 in 1 BOTTLETABLET, COATED601
76420-925-90Spironolactone90 in 1 BOTTLETABLET, COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-925SPIRONOLACTONE TABLET, COATED [ASCLEMED USA, INC.]1Current NDC, 7 package rows20250311_db22e9e5-2d88-4712-a809-c00881edb447.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SpironolactoneSPIRONOLACTONEPreferred Pharmaceuticals Inc.5e456f3c-f93e-41c6-80c5-a737ed70feda2026-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEPreferred Pharmaceuticals Inc.4290b3ec-8993-47d4-bfe3-fcb81d7baed82026-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEREMEDYREPACK INC.7646ca22-710e-4a5c-9613-b829e2f9d5ce2026-08-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEREMEDYREPACK INC.b119ed8a-289a-46c5-9778-6b07e4c061c42026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEPD-Rx Pharmaceuticals, Inc.73564b3d-8ede-4008-b75c-1277153b5bb62026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEPD-Rx Pharmaceuticals, Inc.8a66d90e-5450-4716-8c01-e7dc1967d00d2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEPD-Rx Pharmaceuticals, Inc.8cbe2215-744c-438a-b3d6-b7d6ae7692312026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEREMEDYREPACK INC.8f0291a9-c8a6-4298-a540-23abc01fae092026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONECoupler LLC56050192-c499-64bd-e063-6294a90acbeb2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONECoupler LLC53454970-2c0f-54c3-e063-6294a90aac0a2026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEProficient Rx LP6782c1c1-d1ac-4c07-b7cb-a74699d2f9fe2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEProficient Rx LP6867776e-b4fd-41db-8da8-a5af76eed2802026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEDirect_Rxffd2f3f5-c7c8-0028-e053-6394a90aaf172026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONENuCare Pharmaceuticals,Inc.4b9a20c4-46f2-d572-e063-6294a90a30ad2026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONENuCare Pharmaceuticals, Inc.4b4af7e0-f35b-9bf6-e063-6294a90a83b92026-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEOxford Pharmaceuticals, LLC852684dc-e1c6-4caa-bccb-10ac90bbb3bb2026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONECoupler LLC472ee2ad-7e57-bef1-e063-6394a90a02062025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEA-S Medication Solutionsbb29ea6f-c294-4895-9e9b-544d69651a352025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEA-S Medication Solutionsc328f555-2da8-43ac-bc04-0e89d4d2aa532025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEA-S Medication Solutionscd64e343-e15e-43b1-88b5-a3d5ba23fedf2025-11-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNdb22e9e5-2d88-4712-a809-c00881edb4471
313096spironolactone 25 MG Oral TabletPSNdb22e9e5-2d88-4712-a809-c00881edb4471
198223spironolactone 50 MG Oral TabletPSNdb22e9e5-2d88-4712-a809-c00881edb4471
198222spironolactone 100 MG Oral TabletSCDdb22e9e5-2d88-4712-a809-c00881edb4471
313096spironolactone 25 MG Oral TabletSCDdb22e9e5-2d88-4712-a809-c00881edb4471
198223spironolactone 50 MG Oral TabletSCDdb22e9e5-2d88-4712-a809-c00881edb4471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-925-0176420092501100 TABLET, COATED in 1 BOTTLE (76420-925-01) 2025-03-06NoNoCurrent