Home NDC 31722-096-01 spironolactone
Product NDC 31722-096
Requested package NDC 31722-096-01
11-digit product format 317220096
Labeler code 31722
Product ID 31722-096_3d3f731e-28d0-d9b4-e063-6394a90ad1fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name spironolactone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA217761
Marketing category ANDA
Marketing start 2025-07-25
Substance SPIRONOLACTONE
Active strength 100 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 A217761-001 SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET / ORAL AB 2025-07-25 A217761-002 SPIRONOLACTONE SPIRONOLACTONE 50MG TABLET / ORAL AB 2025-07-25 A217761-003 SPIRONOLACTONE SPIRONOLACTONE 100MG TABLET / ORAL AB 2025-07-25
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.
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 2026-08-01 22:54:32 2026-06 A217761-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2025-07-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A217761-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2025-07-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A217761-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2025-07-25 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198222 Internal RxNorm lookup 198223 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 31722-096-01 spironolactone 100 in 1 BOTTLE TABLET, FILM COATED 100 1 31722-096-05 spironolactone 500 in 1 BOTTLE TABLET, FILM COATED 500 1 31722-096-10 spironolactone 1000 in 1 BOTTLE TABLET, FILM COATED 1000 1 31722-096-30 spironolactone 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 31722-096-01 31722009601 100 TABLET, FILM COATED in 1 BOTTLE (31722-096-01) 2025-07-25 No No Current