Home NDC 68788-8175 Fluvoxamine Maleate
Product NDC 68788-8175
11-digit product format 687888175
Labeler code 68788
Product ID 68788-8175_e8faf176-d195-4e5f-a7dc-a17a05985ec6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluvoxamine Maleate
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA075902
Marketing category ANDA
Marketing start 2022-04-27
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 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 A075902-001 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 A075902-002 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 A075902-003 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07
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 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075902-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB 2001-05-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075902-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB 2001-05-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075902-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB 2001-05-07 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 Fluvoxamine Maleate
Listing expiration 2027-12-31 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 68788-8175-3 Fluvoxamine Maleate 30 in 1 BOTTLE TABLET 30 5 68788-8175-6 Fluvoxamine Maleate 60 in 1 BOTTLE TABLET 60 5 68788-8175-9 Fluvoxamine Maleate 90 in 1 BOTTLE TABLET 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8175 FLUVOXAMINE MALEATE TABLET [PREFERRED PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 3 package rows 20240504_a4e0212a-ce68-4466-a0e4-f87d5d9ff0b3.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluvoxamine Maleate FLUVOXAMINE MALEATE American Health Packaging 0b107225-ed5a-4461-9184-f3f2bad1892f 2026-06-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075902 application number: ANDA075902 Fluvoxamine Maleate FLUVOXAMINE MALEATE Preferred Pharmaceuticals Inc. a4e0212a-ce68-4466-a0e4-f87d5d9ff0b3 2026-04-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075902 application number: ANDA075902 ndc (product): 68788-8175 Fluvoxamine Maleate FLUVOXAMINE MALEATE Bryant Ranch Prepack 4239fc32-e5cb-4393-b90c-742db42b5d07 2026-01-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075902 application number: ANDA075902 Fluvoxamine Maleate FLUVOXAMINE MALEATE Bryant Ranch Prepack 47daea9e-545d-4a67-b2b2-d12c3c98734b 2026-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075902 application number: ANDA075902 Fluvoxamine Maleate FLUVOXAMINE MALEATE PD-Rx Pharmaceuticals, Inc. 9972efbb-46cd-45b7-b71c-35032311b70c 2025-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075902 application number: ANDA075902
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-8175-3 68788817503 30 TABLET in 1 BOTTLE (68788-8175-3) 30 tablet 2022-04-27 0000-00-00 No No Current 68788-8175-6 68788817506 60 TABLET in 1 BOTTLE (68788-8175-6) 60 tablet 2022-04-27 0000-00-00 No No Current 68788-8175-9 68788817509 90 TABLET in 1 BOTTLE (68788-8175-9) 90 tablet 2022-04-27 0000-00-00 No No Current