Home NDC 0832-6025 Fluvoxamine Maleate
Product NDC 0832-6025
11-digit product format 008326025
Labeler code 0832
Product ID 0832-6025_e8d5c618-7a45-447a-bb44-71c9fe5b10c5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluvoxamine Maleate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA220328
Marketing category ANDA
Marketing start 2026-04-30
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220328-001 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-04-30 A220328-002 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-04-30
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 2026-09-14 22:38:34 2026-08 A220328-001 FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220328-002 FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-04-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220328-001 FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220328-002 FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-04-30 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220328-001 FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-04-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220328-002 FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-04-30 a50c72e98297…
Observed Orange Book normalized TE history# 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0832-6025-30 00832602530 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-6025-30) 2026-05-15 No No Current