Home NDC 68788-7219 fluvoxamine maleate
Product NDC 68788-7219
11-digit product format 687887219
Labeler code 68788
Product ID 68788-7219_ebf9e7b9-9f58-4a8f-8034-41129cd4fca6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluvoxamine maleate
Dosage form TABLET, COATED
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application NDA021519
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-07-27
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 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 N021519-001 LUVOX FLUVOXAMINE MALEATE 25MG TABLET / ORAL AB RLD 2007-12-20 N021519-002 LUVOX FLUVOXAMINE MALEATE 50MG TABLET / ORAL AB RLD 2007-12-20 N021519-003 LUVOX FLUVOXAMINE MALEATE 100MG TABLET / ORAL AB RLD 2007-12-20
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 · 123 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 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021519-002 LUVOX 50MG TABLET / ORAL AB RLD 2007-12-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021519-003 LUVOX 100MG TABLET / ORAL AB RLD 2007-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021519-001 LUVOX 25MG TABLET / ORAL AB RLD 2007-12-20 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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 68788-7219-3 fluvoxamine maleate 30 in 1 BOTTLE TABLET, COATED 30 9 68788-7219-6 fluvoxamine maleate 60 in 1 BOTTLE TABLET, COATED 60 9 68788-7219-9 fluvoxamine maleate 90 in 1 BOTTLE TABLET, COATED 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7219 FLUVOXAMINE MALEATE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 3 package rows 20240504_b5b2128d-2363-4966-971f-83219755ecd7.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 REMEDYREPACK INC. 5198b1c8-8dd6-4b8f-bd85-294ac468af53 2026-04-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021519 application number: NDA021519 fluvoxamine maleate FLUVOXAMINE MALEATE Preferred Pharmaceuticals, Inc. b5b2128d-2363-4966-971f-83219755ecd7 2026-04-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021519 application number: NDA021519 ndc (product): 68788-7219 fluvoxamine maleate FLUVOXAMINE MALEATE REMEDYREPACK INC. 88b5207a-d87b-4541-ac6b-aa1c51715fcf 2026-01-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021519 application number: NDA021519 fluvoxamine maleate FLUVOXAMINE MALEATE ANI Pharmaceuticals, Inc. 7ecd83ec-88f5-4f85-9cc2-9068375d8820 2025-08-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021519 application number: NDA021519 fluvoxamine maleate FLUVOXAMINE MALEATE A-S Medication Solutions ddc9e7e8-f041-43bb-970b-cd4b30367637 2025-05-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021519 application number: NDA021519
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68788-7219-3 68788721903 30 TABLET, COATED in 1 BOTTLE (68788-7219-3) 2018-07-27 0000-00-00 No No Current 68788-7219-6 68788721906 60 TABLET, COATED in 1 BOTTLE (68788-7219-6) 2018-07-27 0000-00-00 No No Current 68788-7219-9 68788721909 90 TABLET, COATED in 1 BOTTLE (68788-7219-9) 2018-07-27 0000-00-00 No No Current