fluvoxamine maleate

Generic: fluvoxamine maleate

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluvoxamine maleate
Generic Name fluvoxamine maleate
Labeler endo usa, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

fluvoxamine maleate 150 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 10370-176
Product ID 10370-176_43df09bd-f0c3-4635-8242-4d2110138b84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091476
Listing Expiration 2026-12-31
Marketing Start 2013-03-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10370176
Hyphenated Format 10370-176

Supplemental Identifiers

RxCUI
903873 903879
UPC
0310370175117 0310370176114
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 ANDA091476 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-176-11)
source: ndc

Packages (1)

10370-176-11 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-176-11)

Ingredients (1)

fluvoxamine maleate (150 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": "43df09bd-f0c3-4635-8242-4d2110138b84", "openfda": {"upc": ["0310370175117", "0310370176114"], "unii": ["5LGN83G74V"], "rxcui": ["903873", "903879"], "spl_set_id": ["d492230c-f56a-4759-ba86-7090b9f44063"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-176-11)", "package_ndc": "10370-176-11", "marketing_start_date": "20130313"}], "brand_name": "Fluvoxamine Maleate", "product_id": "10370-176_43df09bd-f0c3-4635-8242-4d2110138b84", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "10370-176", "generic_name": "Fluvoxamine Maleate", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvoxamine Maleate", "active_ingredients": [{"name": "FLUVOXAMINE MALEATE", "strength": "150 mg/1"}], "application_number": "ANDA091476", "marketing_category": "ANDA", "marketing_start_date": "20130313", "listing_expiration_date": "20261231"}