Home NDC 64980-706 Spironolactone
Product NDC 64980-706
11-digit product format 649800706
Labeler code 64980
Product ID 64980-706_1db052c9-3239-4b01-977e-99e9c58962f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Spironolactone
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA219494
Marketing category ANDA
Marketing start 2025-09-15
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 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 A219494-001 SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET / ORAL AB 2025-01-23 A219494-002 SPIRONOLACTONE SPIRONOLACTONE 50MG TABLET / ORAL AB 2025-01-23 A219494-003 SPIRONOLACTONE SPIRONOLACTONE 100MG TABLET / ORAL AB 2025-01-23
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 2026-09-14 22:38:34 2026-08 A219494-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2025-01-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219494-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2025-01-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219494-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2025-01-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219494-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2025-01-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219494-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2025-01-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219494-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2025-01-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219494-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2025-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219494-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2025-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219494-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2025-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219494-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2025-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219494-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2025-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219494-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2025-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219494-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2025-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219494-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2025-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219494-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2025-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219494-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2025-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219494-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2025-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219494-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2025-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219494-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2025-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219494-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2025-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219494-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2025-01-23 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219494-001 SPIRONOLACTONE 25MG TABLET / ORAL AB 2025-01-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219494-002 SPIRONOLACTONE 50MG TABLET / ORAL AB 2025-01-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219494-003 SPIRONOLACTONE 100MG TABLET / ORAL AB 2025-01-23 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 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 64980-706-01 Spironolactone 100 in 1 BOTTLE TABLET 100 1 64980-706-50 Spironolactone 500 in 1 BOTTLE TABLET 500 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64980-706-01 64980070601 100 TABLET in 1 BOTTLE (64980-706-01) 100 tablet 2025-09-15 No No Current 64980-706-50 64980070650 500 TABLET in 1 BOTTLE (64980-706-50) 500 tablet 2025-09-15 No No Current