fluvoxamine maleate

Generic: fluvoxamine maleate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluvoxamine maleate
Generic Name fluvoxamine maleate
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluvoxamine maleate 50 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1974
Product ID 71335-1974_edc23496-df64-4284-9f04-f2b35bf19c00
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075902
Listing Expiration 2027-12-31
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 713351974
Hyphenated Format 71335-1974

Supplemental Identifiers

RxCUI
903891
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
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (71335-1974-1)
  • 30 TABLET in 1 BOTTLE (71335-1974-2)
source: ndc

Packages (2)

71335-1974-1 60 TABLET in 1 BOTTLE (71335-1974-1) 71335-1974-2 30 TABLET in 1 BOTTLE (71335-1974-2)

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": "edc23496-df64-4284-9f04-f2b35bf19c00", "openfda": {"unii": ["5LGN83G74V"], "rxcui": ["903891"], "spl_set_id": ["47daea9e-545d-4a67-b2b2-d12c3c98734b"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-1974-1)", "package_ndc": "71335-1974-1", "marketing_start_date": "20220214"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1974-2)", "package_ndc": "71335-1974-2", "marketing_start_date": "20211014"}], "brand_name": "Fluvoxamine Maleate", "product_id": "71335-1974_edc23496-df64-4284-9f04-f2b35bf19c00", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71335-1974", "generic_name": "Fluvoxamine Maleate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvoxamine Maleate", "active_ingredients": [{"name": "FLUVOXAMINE MALEATE", "strength": "50 mg/1"}], "application_number": "ANDA075902", "marketing_category": "ANDA", "marketing_start_date": "20010710", "listing_expiration_date": "20271231"}