SPIRONOLACTONE

Product NDC
76420-556
Requested package NDC
76420-556-90
11-digit product format
764200556
Labeler code
76420
Product ID
76420-556_f8b9eb31-4486-7638-e053-6394a90aee92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA089424
Marketing category
ANDA
Marketing start
1986-07-23
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
A089424-001SPIRONOLACTONESPIRONOLACTONE25MGTABLET / ORALAB1986-07-23
A089424-002SPIRONOLACTONESPIRONOLACTONE50MGTABLET / ORALAB1999-08-11
A089424-003SPIRONOLACTONESPIRONOLACTONE100MGTABLET / ORALAB1999-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089424-001AB
A089424-002AB
A089424-003AB

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 22:38:342026-08A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-2384e616aacf4f…
2026-09-14 22:38:342026-08A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-1184e616aacf4f…
2026-09-14 22:38:342026-08A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-1184e616aacf4f…
2026-08-18 06:07:402026-07A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-002SPIRONOLACTONE50MGTABLET / ORALAB1999-08-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-003SPIRONOLACTONE100MGTABLET / ORALAB1999-08-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089424-001SPIRONOLACTONE25MGTABLET / ORALAB1986-07-23301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A089424-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A089424-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A089424-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A089424-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A089424-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A089424-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089424-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089424-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089424-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089424-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089424-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089424-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089424-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089424-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089424-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089424-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089424-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089424-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089424-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089424-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A089424-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A089424-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089424-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089424-001AB1301d65b070ca…

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
731894f2-bb1b-4ff6-b8c4-b8722e173199Available 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
76420-556-01SPIRONOLACTONE100 in 1 BOTTLE, PLASTICTABLET1001
76420-556-30SPIRONOLACTONE30 in 1 BOTTLE, PLASTICTABLET301
76420-556-60SPIRONOLACTONE60 in 1 BOTTLE, PLASTICTABLET601
76420-556-90SPIRONOLACTONE90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-556SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [ASCLEMED USA, INC.]1Current NDC, 4 package rows20230409_731894f2-bb1b-4ff6-b8c4-b8722e173199.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 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack3b60de71-2afa-4922-ba3e-0664c2ae29a02026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackd6138536-cdc1-4459-84ff-9dedc0de11052026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackcaf41e17-0461-4667-9eab-62853b9451312026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepacka6e0bf0e-42d3-41e4-854b-811df3bbaaa92026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1fe93db1-0012-4ff6-a4e6-04e2d7e9f6382026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1b29888c-09f9-4cd5-9b4c-920bd159a7272026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackb98b7780-e310-493a-83bd-bb3d93cf8dde2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack753bbc6f-2e50-49c1-b5bf-18f8411a1e8e2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack0cc23419-e6d5-4036-8011-dc1d2455e0cb2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEREMEDYREPACK INC.7c59e03a-b058-4f6e-b104-0836d9b563922026-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEPreferred Pharmaceuticals Inc.3486d831-06b6-4e8f-bd6f-52f7759988f52026-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONESun Pharmaceutical Industries, Inc.c23b6b9b-aec3-48a8-a518-76e4097f64792026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackbe4aa233-1555-4972-858e-46343a7105582026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack11d06acd-1351-4afd-a16a-f035758e2a272026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackca194a2a-ed16-40f6-a78c-45c5f33921702026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackebc4efec-7895-4298-8e75-360bb7992f8d2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack813d199a-9004-4102-8ade-cf877caedafb2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackbb1423e8-1517-44c5-98e0-99be24ce269b2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack2d0655d7-fda6-40c6-907c-acaba0e199872026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1c31c953-05ce-475a-b93f-80aeb12bde952026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSN731894f2-bb1b-4ff6-b8c4-b8722e1731991
313096spironolactone 25 MG Oral TabletPSN731894f2-bb1b-4ff6-b8c4-b8722e1731991
198223spironolactone 50 MG Oral TabletPSN731894f2-bb1b-4ff6-b8c4-b8722e1731991
198222spironolactone 100 MG Oral TabletSCD731894f2-bb1b-4ff6-b8c4-b8722e1731991
313096spironolactone 25 MG Oral TabletSCD731894f2-bb1b-4ff6-b8c4-b8722e1731991
198223spironolactone 50 MG Oral TabletSCD731894f2-bb1b-4ff6-b8c4-b8722e1731991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-556-907642005569090 TABLET in 1 BOTTLE, PLASTIC (76420-556-90) 90 tablet2023-04-07NoNoCurrent