Home NDC 59762-5011-2 spironolactone
Product NDC 59762-5011
Requested package NDC 59762-5011-2
11-digit product format 597625011
Labeler code 59762
Product ID 59762-5011_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 2021-03-31
Substance SPIRONOLACTONE
Active strength 25 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 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-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 · 123 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 2026-02-19 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…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N012151-009 ALDACTONE 25MG TABLET / ORAL AB RLD 1983-12-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N012151-010 ALDACTONE 100MG TABLET / ORAL AB RLD, RS 1983-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N012151-008 ALDACTONE 50MG TABLET / ORAL AB RLD 1982-12-30 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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 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
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59762-5011-2 59762501102 500 TABLET, FILM COATED in 1 BOTTLE (59762-5011-2) 1960-01-21 2021-03-31 No No Current