Spironolactone

Product NDC
50090-6369
11-digit product format
500906369
Labeler code
50090
Product ID
50090-6369_5cfdfcdf-5472-4384-a651-b8d4f65a19f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
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 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
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 · 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 UTC2026-02A040750-001SPIRONOLACTONE25MGTABLET / 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040750-002SPIRONOLACTONE50MGTABLET / ORALAB2006-08-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040750-003SPIRONOLACTONE100MGTABLET / ORALAB2006-08-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040750-001SPIRONOLACTONE25MGTABLET / ORALAB2006-08-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040750-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040750-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040750-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040750-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040750-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040750-001AB18072bd15b7f6…

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 · 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
bb29ea6f-c294-4895-9e9b-544d69651a35Available 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
50090-6369-0Spironolactone100 in 1 BOTTLETABLET, COATED1004
50090-6369-1Spironolactone30 in 1 BOTTLETABLET, COATED304
50090-6369-6Spironolactone90 in 1 BOTTLETABLET, COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6369-0EA - Each50090-63690dcdb71f-c4c7-4168-9f73-72620f0ef95912023-03-13
50090-6369-1EA - Each50090-63692385eaa4-0845-4397-b81a-d3bbccd1606212023-03-13
50090-6369-6EA - Each50090-6369eddda709-431a-402a-ace0-28d9de02dbc912023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6369SPIRONOLACTONE TABLET, COATED [A-S MEDICATION SOLUTIONS]2Current NDC, 3 package rows20230217_bb29ea6f-c294-4895-9e9b-544d69651a35.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
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
SpironolactoneSPIRONOLACTONEREMEDYREPACK INC.b119ed8a-289a-46c5-9778-6b07e4c061c42026-06-01Warnings, 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
SpironolactoneSPIRONOLACTONEREMEDYREPACK INC.7646ca22-710e-4a5c-9613-b829e2f9d5ce2026-04-15Warnings, 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
ndc (product): 50090-6369
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
SpironolactoneSPIRONOLACTONEA-S Medication Solutions08738ad4-1607-4d55-af71-6790477353bd2025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750
SpironolactoneSPIRONOLACTONEPreferred Pharmaceuticals Inc.5e456f3c-f93e-41c6-80c5-a737ed70feda2025-09-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040750
application number: ANDA040750

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSNbb29ea6f-c294-4895-9e9b-544d69651a354
313096spironolactone 25 MG Oral TabletSCDbb29ea6f-c294-4895-9e9b-544d69651a354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6369-050090636900100 TABLET, COATED in 1 BOTTLE (50090-6369-0) 2023-02-10NoNoCurrent
50090-6369-15009063690130 TABLET, COATED in 1 BOTTLE (50090-6369-1) 2023-02-16NoNoCurrent
50090-6369-65009063690690 TABLET, COATED in 1 BOTTLE (50090-6369-6) 2023-02-16NoNoCurrent