Home NDC 50090-7728 Fluvoxamine maleate
Product NDC 50090-7728
11-digit product format 500907728
Labeler code 50090
Product ID 50090-7728_eaa06ce9-31b7-4a55-b075-fe88cb86de8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluvoxamine maleate
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA217917
Marketing category ANDA
Marketing start 2025-02-07
Substance FLUVOXAMINE MALEATE
Active strength 100 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [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 A217917-001 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 A217917-002 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 A217917-003 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22
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 2 · 51 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 2026-02-19 14:30 UTC 2026-02 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217917-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2024-01-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217917-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2024-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217917-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2024-01-22 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 51 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluvoxamine maleate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUVOXAMINE MALEATE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5LGN83G74V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 903884 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 50090-7728-0 Fluvoxamine maleate 90 in 1 BOTTLE TABLET 90 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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluvoxamine maleate FLUVOXAMINE MALEATE Bryant Ranch Prepack c3d59ca9-dd42-4b1c-bd2d-23eb507598b8 2026-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217917 application number: ANDA217917 Fluvoxamine maleate FLUVOXAMINE MALEATE A-S Medication Solutions 35b377d9-5b7a-4d8e-b6c1-4291d02f5dae 2025-10-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217917 application number: ANDA217917 ndc (product): 50090-7728 Fluvoxamine maleate FLUVOXAMINE MALEATE Preferred Pharmaceuticals Inc. 642b7b5e-9f1c-479b-b9b3-bf06774f7b60 2025-09-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217917 application number: ANDA217917 Fluvoxamine maleate FLUVOXAMINE MALEATE Bionpharma Inc. 191912e6-b3c8-be1a-e063-6394a90a8dd4 2025-03-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217917 application number: ANDA217917 Fluvoxamine maleate FLUVOXAMINE MALEATE Bionpharma Inc. 2df4f9cf-5803-d8ea-e063-6394a90ad855 2025-02-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217917 application number: ANDA217917
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-7728-0 50090772800 90 TABLET in 1 BOTTLE (50090-7728-0) 90 tablet 2025-10-17 No No Current