fluvoxamine maleate

Generic: fluvoxamine maleate

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

Drug Facts

Product Profile

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

fluvoxamine maleate 100 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-289
Product ID 69452-289_2fa05c01-e84f-99b2-e063-6394a90af57f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217917
Listing Expiration 2026-12-31
Marketing Start 2024-05-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452289
Hyphenated Format 69452-289

Supplemental Identifiers

RxCUI
903884 903887 903891
UNII
5LGN83G74V

Packaging Origin

Original Packager
true

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
  • 100 TABLET, FILM COATED in 1 BOTTLE (69452-289-20)
source: ndc

Packages (1)

69452-289-20 100 TABLET, FILM COATED in 1 BOTTLE (69452-289-20)

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": "2fa05c01-e84f-99b2-e063-6394a90af57f", "openfda": {"unii": ["5LGN83G74V"], "rxcui": ["903884", "903887", "903891"], "spl_set_id": ["191912e6-b3c8-be1a-e063-6394a90a8dd4"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69452-289-20)", "package_ndc": "69452-289-20", "marketing_start_date": "20240523"}], "brand_name": "Fluvoxamine maleate", "product_id": "69452-289_2fa05c01-e84f-99b2-e063-6394a90af57f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "69452-289", "generic_name": "Fluvoxamine maleate", "labeler_name": "Bionpharma 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": "20240523", "listing_expiration_date": "20261231"}