Home NDC 69238-2027-8 Spironolactone
Product NDC 69238-2027
Requested package NDC 69238-2027-8
11-digit product format 692382027
Labeler code 69238
Product ID 69238-2027_e25b36dd-7948-4481-8994-13658f1f337f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Spironolactone
Dosage form SUSPENSION
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA215572
Marketing category ANDA
Marketing start 2023-09-08
Substance SPIRONOLACTONE
Active strength 25 mg/5mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215572-001 SPIRONOLACTONE SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215572-001 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 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215572-001 SPIRONOLACTONE 25MG/5ML SUSPENSION / ORAL AB 2023-09-05 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/5mL
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 104232 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 69238-2027-2 Spironolactone 473 mL in 1 BOTTLE SUSPENSION 473 6 69238-2027-8 Spironolactone 118 mL in 1 BOTTLE SUSPENSION 118 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-2027 SPIRONOLACTONE SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC] 6 Current NDC, 2 package rows 20230908_1ed9a2cb-d666-43db-b515-f9615fa6da25.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 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 69238-2027-8 69238202708 118 mL in 1 BOTTLE (69238-2027-8) 118 ml 2023-09-08 No No Current