fluvoxamine maleate

Generic: fluvoxamine maleate

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluvoxamine maleate
Generic Name fluvoxamine maleate
Labeler apotex corp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluvoxamine maleate 100 mg/1

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-0166
Product ID 60505-0166_d1dc7389-27a2-60cd-7d33-9f0dd29a95b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075902
Listing Expiration 2026-12-31
Marketing Start 2001-07-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605050166
Hyphenated Format 60505-0166

Supplemental Identifiers

RxCUI
903884 903887 903891
UPC
0360505016617 0360505016518 0360505016419
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 ANDA075902 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (60505-0166-1)
source: ndc

Packages (1)

60505-0166-1 100 TABLET in 1 BOTTLE (60505-0166-1)

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": "d1dc7389-27a2-60cd-7d33-9f0dd29a95b4", "openfda": {"upc": ["0360505016617", "0360505016518", "0360505016419"], "unii": ["5LGN83G74V"], "rxcui": ["903884", "903887", "903891"], "spl_set_id": ["6eeb14df-6fcf-a737-5359-5744eb4accea"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (60505-0166-1)", "package_ndc": "60505-0166-1", "marketing_start_date": "20010710"}], "brand_name": "Fluvoxamine Maleate", "product_id": "60505-0166_d1dc7389-27a2-60cd-7d33-9f0dd29a95b4", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "60505-0166", "generic_name": "Fluvoxamine Maleate", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvoxamine Maleate", "active_ingredients": [{"name": "FLUVOXAMINE MALEATE", "strength": "100 mg/1"}], "application_number": "ANDA075902", "marketing_category": "ANDA", "marketing_start_date": "20010710", "listing_expiration_date": "20261231"}