fluvoxamine maleate

Generic: fluvoxamine maleate

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluvoxamine maleate
Generic Name fluvoxamine maleate
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluvoxamine maleate 25 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-931
Product ID 62135-931_2c617129-3c30-3713-e063-6294a90af923
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075900
Listing Expiration 2026-12-31
Marketing Start 2006-02-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135931
Hyphenated Format 62135-931

Supplemental Identifiers

RxCUI
903884 903887 903891
UPC
0362135933302 0362135931902 0362135932602
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 ANDA075900 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (62135-931-90)
source: ndc

Packages (1)

62135-931-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-931-90)

Ingredients (1)

fluvoxamine maleate (25 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": "2c617129-3c30-3713-e063-6294a90af923", "openfda": {"upc": ["0362135933302", "0362135931902", "0362135932602"], "unii": ["5LGN83G74V"], "rxcui": ["903884", "903887", "903891"], "spl_set_id": ["b8320308-084f-43fb-9b1d-5620a0efaf46"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62135-931-90)", "package_ndc": "62135-931-90", "marketing_start_date": "20241218"}], "brand_name": "Fluvoxamine Maleate", "product_id": "62135-931_2c617129-3c30-3713-e063-6294a90af923", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "62135-931", "generic_name": "Fluvoxamine Maleate", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvoxamine Maleate", "active_ingredients": [{"name": "FLUVOXAMINE MALEATE", "strength": "25 mg/1"}], "application_number": "ANDA075900", "marketing_category": "ANDA", "marketing_start_date": "20060223", "listing_expiration_date": "20261231"}