fluvoxamine maleate

Generic: fluvoxamine maleate

Labeler: preferred pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

fluvoxamine maleate 100 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-7219
Product ID 68788-7219_f2e66421-c598-41f1-8322-f4d626d95266
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021519
Listing Expiration 2026-12-31
Marketing Start 2018-07-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687887219
Hyphenated Format 68788-7219

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 NDA021519 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (68788-7219-3)
  • 60 TABLET, COATED in 1 BOTTLE (68788-7219-6)
  • 90 TABLET, COATED in 1 BOTTLE (68788-7219-9)
source: ndc

Packages (3)

68788-7219-3 30 TABLET, COATED in 1 BOTTLE (68788-7219-3) 68788-7219-6 60 TABLET, COATED in 1 BOTTLE (68788-7219-6) 68788-7219-9 90 TABLET, COATED in 1 BOTTLE (68788-7219-9)

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": "f2e66421-c598-41f1-8322-f4d626d95266", "openfda": {"unii": ["5LGN83G74V"], "rxcui": ["903884"], "spl_set_id": ["b5b2128d-2363-4966-971f-83219755ecd7"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (68788-7219-3)", "package_ndc": "68788-7219-3", "marketing_start_date": "20180727"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (68788-7219-6)", "package_ndc": "68788-7219-6", "marketing_start_date": "20180727"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (68788-7219-9)", "package_ndc": "68788-7219-9", "marketing_start_date": "20180727"}], "brand_name": "fluvoxamine maleate", "product_id": "68788-7219_f2e66421-c598-41f1-8322-f4d626d95266", "dosage_form": "TABLET, COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68788-7219", "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": "NDA021519", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20180727", "listing_expiration_date": "20261231"}