fluvoxamine maleate

Generic: fluvoxamine maleate

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluvoxamine maleate
Generic Name fluvoxamine maleate
Labeler upsher-smith laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluvoxamine maleate 50 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-1671
Product ID 0832-1671_45afd276-9f2a-23cd-e063-6294a90a0991
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075888
Marketing Start 2000-11-29
Marketing End 2026-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08321671
Hyphenated Format 0832-1671

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 ANDA075888 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0832-1671-11)
source: ndc

Packages (1)

0832-1671-11 100 TABLET, FILM COATED in 1 BOTTLE (0832-1671-11)

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": "45afd276-9f2a-23cd-e063-6294a90a0991", "openfda": {"unii": ["5LGN83G74V"], "rxcui": ["903884", "903887", "903891"], "spl_set_id": ["52b29024-b639-4c88-ac6c-0c64dbd204f4"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0832-1671-11)", "package_ndc": "0832-1671-11", "marketing_end_date": "20260331", "marketing_start_date": "20200108"}], "brand_name": "Fluvoxamine maleate", "product_id": "0832-1671_45afd276-9f2a-23cd-e063-6294a90a0991", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0832-1671", "generic_name": "Fluvoxamine maleate", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvoxamine maleate", "active_ingredients": [{"name": "FLUVOXAMINE MALEATE", "strength": "50 mg/1"}], "application_number": "ANDA075888", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20001129"}