Home NDC 72888-040 Spironolactone and hydrochlorothiazide
Product NDC 72888-040
11-digit product format 728880040
Labeler code 72888
Product ID 72888-040_5b333a2a-14ce-8106-e063-6394a90aff6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Spironolactone and hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Advagen Pharma Ltd.
Application ANDA220884
Marketing category ANDA
Marketing start 2026-09-10
Substance SPIRONOLACTONE; HYDROCHLOROTHIAZIDE
Active strength 25; 25 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220884-001 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25MG;25MG TABLET / ORAL AB 2026-09-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220884-001 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.
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 2026-09-14 22:38:34 2026-08 A220884-001 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL AB 2026-09-10 84e616aacf4f…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A220884-001 AB 1 84e616aacf4f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Spironolactone and hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SPIRONOLACTONE 25 mg/1 HYDROCHLOROTHIAZIDE 25 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72888-040-01 72888004001 30 TABLET in 1 BOTTLE (72888-040-01) 30 tablet 2026-09-10 No No Current 72888-040-02 72888004002 100 TABLET in 1 BOTTLE (72888-040-02) 100 tablet 2026-09-10 No No Current 72888-040-03 72888004003 1000 TABLET in 1 BOTTLE (72888-040-03) 1000 tablet 2026-09-10 No No Current