fluvoxamine maleate

Generic: fluvoxamine maleate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluvoxamine maleate
Generic Name fluvoxamine maleate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluvoxamine maleate 100 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-221
Product ID 72789-221_401e3db8-8a12-7d79-e063-6394a90a91f1
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 72789221
Hyphenated Format 72789-221

Supplemental Identifiers

RxCUI
903884
UNII
5LGN83G74V

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
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-221-30)
source: ndc

Packages (1)

72789-221-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-221-30)

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": "401e3db8-8a12-7d79-e063-6394a90a91f1", "openfda": {"unii": ["5LGN83G74V"], "rxcui": ["903884"], "spl_set_id": ["9972efbb-46cd-45b7-b71c-35032311b70c"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-221-30)", "package_ndc": "72789-221-30", "marketing_start_date": "20220118"}], "brand_name": "Fluvoxamine Maleate", "product_id": "72789-221_401e3db8-8a12-7d79-e063-6394a90a91f1", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72789-221", "generic_name": "Fluvoxamine Maleate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}