Home NDC 72789-292 Spironolactone
Product NDC 72789-292
11-digit product format 727890292
Labeler code 72789
Product ID 72789-292_56d34347-10f6-121b-e063-6294a90a1bf1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Spironolactone
Dosage form TABLET, COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA040750
Marketing category ANDA
Marketing start 2021-01-04
Substance SPIRONOLACTONE
Active strength 100 mg/1
Pharmacologic classes Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
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 · 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 · 129 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 2026-09-14 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040750-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2006-08-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040750-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2006-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040750-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2006-08-29 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 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 100 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 198222 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 72789-292-30 Spironolactone 30 in 1 BOTTLE, PLASTIC TABLET, COATED 30 10 72789-292-60 Spironolactone 60 in 1 BOTTLE, PLASTIC TABLET, COATED 60 10 72789-292-82 Spironolactone 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 10 72789-292-90 Spironolactone 90 in 1 BOTTLE, PLASTIC TABLET, COATED 90 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-292 SPIRONOLACTONE TABLET, COATED [PD-RX PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 4 package rows 20241210_8cbe2215-744c-438a-b3d6-b7d6ae769231.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 Marketing end Sample Exclude flag Status 72789-292-30 72789029230 30 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-292-30) 2022-12-08 0000-00-00 No No Current 72789-292-60 72789029260 60 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-292-60) 2022-12-08 0000-00-00 No No Current 72789-292-82 72789029282 500 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-292-82) 2022-12-08 0000-00-00 No No Current 72789-292-90 72789029290 90 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-292-90) 2022-12-08 0000-00-00 No No Current