Home NDC 0025-1001 Aldactone
Product NDC 0025-1001
11-digit product format 000251001
Labeler code 0025
Product ID 0025-1001_22946678-dcad-4518-9bc6-cbdf51a38c16
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name spironolactone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA012151
Marketing category NDA
Marketing start 1960-01-21
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-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# 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.
Additional Listing Data#
Finished product Yes
Brand name base Aldactone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SPIRONOLACTONE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 27O7W4T232 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198222 Internal RxNorm lookup 198223 Internal RxNorm lookup 200817 Internal RxNorm lookup 200820 Internal RxNorm lookup 200825 Internal RxNorm lookup 313096 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0025-1001-31 Aldactone 100 in 1 BOTTLE TABLET, FILM COATED 100 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SPIRONOLACTONE ACTIVE INGREDIENT 27O7W4T232 ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 SPIRONOLACTONE ACTIVE MOIETY 27O7W4T232 ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 CALCIUM SULFATE DIHYDRATE INACTIVE INGREDIENT 4846Q921YM ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 HYPROMELLOSE 2910 (15000 MPA.S) INACTIVE INGREDIENT 288VBX44JC ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 POVIDONES INACTIVE INGREDIENT FZ989GH94E ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0025-1001 ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 24 Current NDC, Legacy NDC, 1 package rows 20241225_0fed2822-3a03-4b64-9857-c682fcd462bc.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0025-1001-31 00025100131 100 TABLET, FILM COATED in 1 BOTTLE (0025-1001-31) 1960-01-21 0000-00-00 No No Current