Home NDC 72189-497-90 Spironolactone
Product NDC 72189-497
Requested package NDC 72189-497-90
11-digit product format 721890497
Labeler code 72189
Product ID 72189-497_4c4b0c1a-d843-08bc-e063-6394a90ad546
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Spironolactone
Dosage form TABLET, COATED
Route ORAL
Labeler Direct_Rx
Application ANDA040750
Marketing category ANDA
Marketing start 2023-07-06
Substance SPIRONOLACTONE
Active strength 25 mg/1
Pharmacologic classes Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-497 72189-497-90 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-497 72189-497-90 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A040750-001 SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 A040750-002 SPIRONOLACTONE SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 A040750-003 SPIRONOLACTONE SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29
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 · 132 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 2026-10-15 13:18:30 2026-09 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 108 observed states.
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
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 72189-497-30 Spironolactone 30 in 1 BOTTLE TABLET, COATED 30 3 72189-497-90 Spironolactone 90 in 1 BOTTLE TABLET, COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-497 SPIRONOLACTONE TABLET, COATED [DIRECT_RX] 2 Current NDC, 2 package rows 20250123_ffd2f3f5-c7c8-0028-e053-6394a90aaf17.zip
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 2 of 2 · 25 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72189-497-90 72189049790 90 TABLET, COATED in 1 BOTTLE (72189-497-90) 2023-07-06 No No Current