Home NDC 31722-065 Fluvoxamine Maleate
Product NDC 31722-065
11-digit product format 317220065
Labeler code 31722
Product ID 31722-065_3d922dc6-629d-73e8-e063-6294a90a7d09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluvoxamine Maleate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA217024
Marketing category ANDA
Marketing start 2025-07-30
Substance FLUVOXAMINE MALEATE
Active strength 150 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217024-001 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-30 A217024-002 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 A217024-001 FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217024-002 FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217024-001 FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217024-002 FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217024-001 FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217024-002 FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-30 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217024-001 FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217024-002 FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-30 a50c72e98297…
Observed Orange Book normalized TE history# 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 150 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 903873 Internal RxNorm lookup 903879 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 31722-065-01 Fluvoxamine Maleate 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 1 31722-065-30 Fluvoxamine Maleate 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 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 · 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 31722-065-01 31722006501 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-065-01) 2025-07-30 No No Current 31722-065-30 31722006530 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-065-30) 2025-07-30 No No Current