SPIRONOLACTONE

Product NDC
72162-1624
11-digit product format
721621624
Labeler code
72162
Product ID
72162-1624_a2903367-d7ba-42ba-b6c1-69c699e1016b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2027-12-31
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
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
3791d79c-d960-4790-b689-ea32ddf7226aAvailable 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
72162-1624-0SPIRONOLACTONE1000 in 1 BOTTLETABLET1000109
72162-1624-1SPIRONOLACTONE100 in 1 BOTTLETABLET100109
72162-1624-3SPIRONOLACTONE30 in 1 BOTTLETABLET30109
72162-1624-5SPIRONOLACTONE500 in 1 BOTTLETABLET500109
72162-1624-6SPIRONOLACTONE60 in 1 BOTTLETABLET60109
72162-1624-9SPIRONOLACTONE90 in 1 BOTTLETABLET90109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1624-0EA - Each72162-162434b5f845-d3a5-4201-896c-c73588c47ac712025-05-14
72162-1624-1EA - Each72162-162478c7cae0-2b4e-460b-9ee2-b656d9ff70e612023-07-06
72162-1624-3EA - Each72162-16244b6fd20b-e72c-427e-a885-6f56a62abd0612024-01-04
72162-1624-5EA - Each72162-16247bcf5f56-f2e1-4fb5-b222-91784fd75fcf12024-10-04
72162-1624-6EA - Each72162-1624b437eb85-1aed-4bfd-a90f-51a1de6a35a812024-01-04
72162-1624-9EA - Each72162-1624e3032663-7f96-4db7-af35-45c81aa766ae12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1624SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]108Current NDC, 6 package rows20250313_3791d79c-d960-4790-b689-ea32ddf7226a.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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackcae68fd6-5161-4650-bcde-6db98cbe6c8b2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackb7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d2026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack3791d79c-d960-4790-b689-ea32ddf7226a2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
ndc (product): 72162-1624
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackcbc817de-5ea8-4139-9c13-02bac8ff93c32026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackd4cf1136-df3a-4fc2-9a21-9032949eca412026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEAphena Pharma Solutions - Tennessee, LLC45232668-6952-80a0-e063-6294a90a6e4b2025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEAphena Pharma Solutions - Tennessee, LLCfb961096-edbb-45ad-96b7-61c2f9b98cf92023-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEProficient Rx LP416ce231-fc8d-4ba0-a1ce-d5e054cf025e2023-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEA-S Medication Solutionsbe568fbd-3c3d-417c-ae96-75a78ca4b7cd2023-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEA-S Medication Solutions4514fa40-613e-46f5-bee4-3edc7cc9863f2023-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEA-S Medication Solutions200b2a6a-f263-463e-a2e1-f4f74058a9242023-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEAsclemed USA, Inc.731894f2-bb1b-4ff6-b8c4-b8722e1731992023-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424
SPIRONOLACTONESPIRONOLACTONEProficient Rx LP18f11eed-9ef6-43f6-8db0-720c275638712023-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089424
application number: ANDA089424

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN3791d79c-d960-4790-b689-ea32ddf7226a109
313096spironolactone 25 MG Oral TabletSCD3791d79c-d960-4790-b689-ea32ddf7226a109
313096spironolactone 25 MG Oral TabletPSN45232668-6952-80a0-e063-6294a90a6e4b2
313096spironolactone 25 MG Oral TabletSCD45232668-6952-80a0-e063-6294a90a6e4b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1624-0721621624001000 TABLET in 1 BOTTLE (72162-1624-0) 1000 tablet2023-11-20NoNoCurrent
72162-1624-172162162401100 TABLET in 1 BOTTLE (72162-1624-1) 100 tablet2024-04-08NoNoCurrent
72162-1624-37216216240330 TABLET in 1 BOTTLE (72162-1624-3) 30 tablet2025-09-15NoNoCurrent
72162-1624-572162162405500 TABLET in 1 BOTTLE (72162-1624-5) 500 tablet2025-01-13NoNoCurrent
72162-1624-67216216240660 TABLET in 1 BOTTLE (72162-1624-6) 60 tablet2026-03-30NoNoCurrent
72162-1624-97216216240990 TABLET in 1 BOTTLE (72162-1624-9) 90 tablet2026-03-30NoNoCurrent