Home NDC 59762-5012 spironolactone
Product NDC 59762-5012
11-digit product format 597625012
Labeler code 59762
Product ID 59762-5012_82d1b2a5-4b7d-4d49-a0d3-4001cd6e1bb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name spironolactone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Greenstone LLC
Application NDA012151
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1960-01-21
Marketing end 2021-01-31
Substance SPIRONOLACTONE
Active strength 50 mg/1
Pharmacologic classes Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59762-5012-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59762-5012-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59762-5012-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59762-5012-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59762-5012-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59762-5012-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59762-5012-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59762-5012-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59762-5012-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 59762-5012-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 59762-5012-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 59762-5012-1 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SPIRONOLACTONE ACTIVE INGREDIENT 27O7W4T232 SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12 SPIRONOLACTONE ACTIVE MOIETY 27O7W4T232 SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12 CALCIUM SULFATE DIHYDRATE INACTIVE INGREDIENT 4846Q921YM SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12 HYPROMELLOSE 2910 (15000 MPA.S) INACTIVE INGREDIENT 288VBX44JC SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12 POVIDONES INACTIVE INGREDIENT FZ989GH94E SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC] 12
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aldactone SPIRONOLACTONE Pfizer Laboratories Div Pfizer Inc 0fed2822-3a03-4b64-9857-c682fcd462bc 2025-11-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 012151 application number: NDA012151