Home NDC 70771-1958 Fluvoxamine maleate extended-release
Product NDC 70771-1958
11-digit product format 707711958
Labeler code 70771
Product ID 70771-1958_d45aa001-af6b-41f2-ac88-c72411621202
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluvoxamine maleate extended-release
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA220447
Marketing category ANDA
Marketing start 2026-08-04
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 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 A220447-001 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-07-21 A220447-002 FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-07-21
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 A220447-001 FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220447-002 FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-07-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220447-001 FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220447-002 FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-07-21 caaa826d4ba7…
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 extended-release
Listing expiration 2027-12-31 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.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70771-1958-3 70771195803 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1958-3) 2026-08-04 No No Current