Home Applications 012151 Application 012151
Type NDA
Sponsor GD SEARLE LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 008 ALDACTONE SPIRONOLACTONE TABLET;ORAL 50MG Yes No 009 ALDACTONE SPIRONOLACTONE TABLET;ORAL 25MG Yes No 010 ALDACTONE SPIRONOLACTONE TABLET;ORAL 100MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N012151-008 ALDACTONE SPIRONOLACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 N012151-009 ALDACTONE SPIRONOLACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 N012151-010 ALDACTONE SPIRONOLACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 28 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0025-1001 Aldactone spironolactone Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1001 Aldactone spironolactone Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1001 Aldactone spironolactone G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1001 Aldactone spironolactone G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1001 Aldactone spironolactone Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1001 Aldactone spironolactone Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1031 Aldactone spironolactone Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1031 Aldactone spironolactone Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1031 Aldactone spironolactone G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1031 Aldactone spironolactone G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1031 Aldactone spironolactone Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1031 Aldactone spironolactone Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1041 Aldactone spironolactone Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1041 Aldactone spironolactone Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1041 Aldactone spironolactone G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1041 Aldactone spironolactone G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1041 Aldactone spironolactone Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1041 Aldactone spironolactone Pfizer Laboratories Div Pfizer Inc NDA Current 59762-5011 spironolactone spironolactone Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-5011 spironolactone spironolactone Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-5011 spironolactone spironolactone Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-5011 spironolactone spironolactone Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-5012 spironolactone spironolactone Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-5012 spironolactone spironolactone Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-5012 spironolactone spironolactone Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-5012 spironolactone spironolactone Greenstone LLC NDA AUTHORIZED GENERIC Current 70518-1396 Aldactone spironolactone REMEDYREPACK INC. NDA Current 70518-1396 Aldactone spironolactone REMEDYREPACK INC. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84179 SUPPL 2025-11-18 84177 SUPPL 2025-11-17 72971 SUPPL 2022-12-21 72969 SUPPL 2022-12-21 64145 SUPPL 2020-07-30 64117 SUPPL 2020-07-29 52909 SUPPL 2018-03-12 52875 SUPPL 2018-03-08 10797 SUPPL 2014-10-24 10796 SUPPL 2013-06-18 309 SUPPL 2013-06-13 308 SUPPL 2012-09-20 33076 SUPPL 2012-09-17 11992 SUPPL 2011-09-26 10795 SUPPL 2009-01-02 11991 SUPPL 2008-11-26