fluvoxamine maleate

Generic: fluvoxamine maleate

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluvoxamine maleate
Generic Name fluvoxamine maleate
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluvoxamine maleate 100 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-4011
Product ID 68788-4011_642b7b5e-9f1c-479b-b9b3-bf06774f7b60
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217917
Listing Expiration 2026-12-31
Marketing Start 2025-09-04

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687884011
Hyphenated Format 68788-4011

Supplemental Identifiers

RxCUI
903884
UNII
5LGN83G74V

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fluvoxamine maleate (source: ndc)
Generic Name fluvoxamine maleate (source: ndc)
Application Number ANDA217917 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68788-4011-3)
  • 60 TABLET in 1 BOTTLE (68788-4011-6)
  • 90 TABLET in 1 BOTTLE (68788-4011-9)
source: ndc

Packages (3)

68788-4011-3 30 TABLET in 1 BOTTLE (68788-4011-3) 68788-4011-6 60 TABLET in 1 BOTTLE (68788-4011-6) 68788-4011-9 90 TABLET in 1 BOTTLE (68788-4011-9)

Ingredients (1)

fluvoxamine maleate (100 mg/1)

Linked Drug Pages (1)

Fluvoxamine maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "642b7b5e-9f1c-479b-b9b3-bf06774f7b60", "openfda": {"unii": ["5LGN83G74V"], "rxcui": ["903884"], "spl_set_id": ["642b7b5e-9f1c-479b-b9b3-bf06774f7b60"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-4011-3)", "package_ndc": "68788-4011-3", "marketing_start_date": "20250904"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-4011-6)", "package_ndc": "68788-4011-6", "marketing_start_date": "20250904"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-4011-9)", "package_ndc": "68788-4011-9", "marketing_start_date": "20250904"}], "brand_name": "Fluvoxamine maleate", "product_id": "68788-4011_642b7b5e-9f1c-479b-b9b3-bf06774f7b60", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68788-4011", "generic_name": "Fluvoxamine maleate", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvoxamine maleate", "active_ingredients": [{"name": "FLUVOXAMINE MALEATE", "strength": "100 mg/1"}], "application_number": "ANDA217917", "marketing_category": "ANDA", "marketing_start_date": "20250904", "listing_expiration_date": "20261231"}