Home NDC 62135-932 Fluvoxamine Maleate
Product NDC 62135-932
11-digit product format 621350932
Labeler code 62135
Product ID 62135-932_2c617129-3c30-3713-e063-6294a90af923
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluvoxamine Maleate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA075900
Marketing category ANDA
Marketing start 2006-02-23
Substance FLUVOXAMINE MALEATE
Active strength 50 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 A075900-001 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 A075900-002 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 A075900-003 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23
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 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075900-002 FLUVOXAMINE MALEATE 50MG TABLET / ORAL 2006-02-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075900-003 FLUVOXAMINE MALEATE 100MG TABLET / ORAL 2006-02-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075900-001 FLUVOXAMINE MALEATE 25MG TABLET / ORAL 2006-02-23 8072bd15b7f6…
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 50 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 903884 Internal RxNorm lookup 903887 Internal RxNorm lookup 903891 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 62135-932-60 Fluvoxamine Maleate 60 in 1 BOTTLE TABLET, FILM COATED 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-932 FLUVOXAMINE MALEATE TABLET, FILM COATED [CHARTWELL RX, LLC] 2 Current NDC, 1 package rows 20250125_b8320308-084f-43fb-9b1d-5620a0efaf46.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 Marketing start Sample Exclude flag Status 62135-932-60 62135093260 60 TABLET, FILM COATED in 1 BOTTLE (62135-932-60) 2024-12-18 No No Current