Home NDC 0025-1021 ALDACTAZIDE
Product NDC 0025-1021
11-digit product format 000251021
Labeler code 0025
Product ID 0025-1021_f6b71298-6d0c-4af3-98d8-51be7510a7b3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name spironolactone and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA012616
Marketing category NDA
Marketing start 1978-01-01
Marketing end 0000-00-00
Substance HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
Active strength 50 mg/1; mg/1
Pharmacologic classes Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag No
Listing certified through 2024-12-31
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 · 12 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 0025-1021-31 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 0025-1021-31 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 0025-1021-31 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 0025-1021-31 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 0025-1021-31 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 0025-1021-31 cdf11ea48f46…ba0047e9e063…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N012616-004 ALDACTAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 N012616-005 ALDACTAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 50MG;50MG TABLET / ORAL RLD 1982-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N012616-004 AB
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 3 · 84 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 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD 1982-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD, RS 1982-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD, RS 1982-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD, RS 1982-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD, RS 1982-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N012616-004 ALDACTAZIDE 25MG;25MG TABLET / ORAL AB RLD 1982-12-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N012616-005 ALDACTAZIDE 50MG;50MG TABLET / ORAL RLD, RS 1982-12-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13 SPIRONOLACTONE ACTIVE INGREDIENT 27O7W4T232 ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13 SPIRONOLACTONE ACTIVE MOIETY 27O7W4T232 ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13 CALCIUM SULFATE INACTIVE INGREDIENT WAT0DDB505 ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13 POVIDONES INACTIVE INGREDIENT FZ989GH94E ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ALDACTAZIDE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 13
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0025-1021-31 00025102131 100 TABLET, FILM COATED in 1 BOTTLE (0025-1021-31) 1978-01-01 0000-00-00 No No Current