fluvoxamine maleate

Generic: fluvoxamine maleate

Labeler: ani 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 ani pharmaceuticals, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

fluvoxamine maleate 50 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-159
Product ID 62559-159_cfb2098d-d30b-4a8e-84c1-aeb8065b519c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021519
Listing Expiration 2026-12-31
Marketing Start 2011-08-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559159
Hyphenated Format 62559-159

Supplemental Identifiers

RxCUI
903884 903887 903891
UPC
0362559159012 0362559158015 0362559160018
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 NDA021519 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (62559-159-01)
source: ndc

Packages (1)

62559-159-01 100 TABLET, COATED in 1 BOTTLE (62559-159-01)

Ingredients (1)

fluvoxamine maleate (50 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": "cfb2098d-d30b-4a8e-84c1-aeb8065b519c", "openfda": {"upc": ["0362559159012", "0362559158015", "0362559160018"], "unii": ["5LGN83G74V"], "rxcui": ["903884", "903887", "903891"], "spl_set_id": ["7ecd83ec-88f5-4f85-9cc2-9068375d8820"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (62559-159-01)", "package_ndc": "62559-159-01", "marketing_start_date": "20110809"}], "brand_name": "fluvoxamine maleate", "product_id": "62559-159_cfb2098d-d30b-4a8e-84c1-aeb8065b519c", "dosage_form": "TABLET, COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "62559-159", "generic_name": "Fluvoxamine maleate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluvoxamine maleate", "active_ingredients": [{"name": "FLUVOXAMINE MALEATE", "strength": "50 mg/1"}], "application_number": "NDA021519", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20110809", "listing_expiration_date": "20261231"}