FDA.reportPublic FDA data

Spironolactone

Product NDC
71610-102
Requested package NDC
71610-102-60
11-digit product format
716100102
Labeler code
71610
Product ID
71610-102_c9e366cc-e9b4-4e14-8c40-8daf2fe265ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091426
Marketing category
ANDA
Marketing start
2010-08-02
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
A091426-001SPIRONOLACTONESPIRONOLACTONE25MGTABLET / ORALAB2010-07-02
A091426-002SPIRONOLACTONESPIRONOLACTONE50MGTABLET / ORALAB2010-07-02
A091426-003SPIRONOLACTONESPIRONOLACTONE100MGTABLET / ORALAB2010-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091426-001AB
A091426-002AB
A091426-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091426-001SPIRONOLACTONE25MGTABLET / ORALAB2010-07-02a50c72e98297…
2026-08-01 22:54:322026-06A091426-002SPIRONOLACTONE50MGTABLET / ORALAB2010-07-02a50c72e98297…
2026-08-01 22:54:322026-06A091426-003SPIRONOLACTONE100MGTABLET / ORALAB2010-07-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091426-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091426-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091426-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SpironolactoneSPIRONOLACTONEBryant Ranch Prepack31aeab13-8f71-49f1-b101-8b0abb21b0dc2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091426
application number: ANDA091426
SpironolactoneSPIRONOLACTONEQPharma, Inceb314e91-6dd5-4bdb-af35-5d147b20339c2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091426
application number: ANDA091426
SpironolactoneSPIRONOLACTONEAmneal Pharmaceuticals of New York LLC951b8948-dc0f-4aef-9910-82c252de936d2025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091426
application number: ANDA091426
SpironolactoneSPIRONOLACTONEPharmPak, Inc.c450e66a-0f05-445e-b1df-df2b17a2f0642022-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091426
application number: ANDA091426
SpironolactoneSPIRONOLACTONEAmneal Pharmaceuticals LLCfb66327e-8261-46ae-b39a-4fa79d5208442020-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091426
application number: ANDA091426
SpironolactoneSPIRONOLACTONEAphena Pharma Solutions - Tennessee, LLCbf58378f-8304-4799-b0c0-fad8697149ab2018-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091426
application number: ANDA091426
ndc (package): 71610-102-60
ndc (product): 71610-102
ndc11 (package): 71610010260

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
bf58378f-8304-4799-b0c0-fad8697149abAvailable 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
71610-102-60Spironolactone90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-102-60EA - Each71610-102b0a0c63f-ff7c-4d9e-afaf-5df13844e30712018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-102SPIRONOLACTONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20180816_bf58378f-8304-4799-b0c0-fad8697149ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSNbf58378f-8304-4799-b0c0-fad8697149ab1
313096spironolactone 25 MG Oral TabletSCDbf58378f-8304-4799-b0c0-fad8697149ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-102-607161001026090 TABLET in 1 BOTTLE (71610-102-60) 90 tablet2018-07-260000-00-00NoNoCurrent