FDA.reportPublic FDA data

Application 012151

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
008ALDACTONESPIRONOLACTONETABLET;ORAL50MGYesNo
009ALDACTONESPIRONOLACTONETABLET;ORAL25MGYesNo
010ALDACTONESPIRONOLACTONETABLET;ORAL100MGYesYes

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
N012151-008ALDACTONESPIRONOLACTONE50MGTABLET / ORALABRLD1982-12-30
N012151-009ALDACTONESPIRONOLACTONE25MGTABLET / ORALABRLD1983-12-30
N012151-010ALDACTONESPIRONOLACTONE100MGTABLET / ORALABRLD, RS1983-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N012151-008AB
N012151-009AB
N012151-010AB

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 22:54:322026-06N012151-008ALDACTONE50MGTABLET / ORALABRLD1982-12-30a50c72e98297…
2026-08-01 22:54:322026-06N012151-009ALDACTONE25MGTABLET / ORALABRLD1983-12-30a50c72e98297…
2026-08-01 22:54:322026-06N012151-010ALDACTONE100MGTABLET / ORALABRLD, RS1983-12-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N012151-008AB1a50c72e98297…
2026-08-01 22:54:322026-06N012151-009AB1a50c72e98297…
2026-08-01 22:54:322026-06N012151-010AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AldactoneSPIRONOLACTONEPfizer Laboratories Div Pfizer Inc0fed2822-3a03-4b64-9857-c682fcd462bc2025-11-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 012151
application number: NDA012151
ndc (product): 0025-1031
ndc (product): 0025-1041
ndc (product): 0025-1001

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-1001AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1001AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1001AldactonespironolactoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1001AldactonespironolactoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1001AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1001AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1031AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1031AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1031AldactonespironolactoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1031AldactonespironolactoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1031AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1031AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1041AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1041AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1041AldactonespironolactoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1041AldactonespironolactoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1041AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1041AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
59762-5011spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5011spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5011spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5011spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5012spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5012spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5012spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5012spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
70518-1396AldactonespironolactoneREMEDYREPACK INC.NDACurrent
70518-1396AldactonespironolactoneREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84179SUPPL 2025-11-18
84177SUPPL 2025-11-17
72971SUPPL2022-12-21
72969SUPPL2022-12-21
64145SUPPL2020-07-30
64117SUPPL2020-07-29
52909SUPPL2018-03-12
52875SUPPL2018-03-08
10797SUPPL2014-10-24
10796SUPPL2013-06-18
309SUPPL2013-06-13
308SUPPL2012-09-20
33076SUPPL2012-09-17
11992SUPPL2011-09-26
10795SUPPL2009-01-02
11991SUPPL2008-11-26