fluvoxamine maleate

Generic: fluvoxamine maleate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name fluvoxamine maleate
Generic Name fluvoxamine maleate
Labeler remedyrepack inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

fluvoxamine maleate 50 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1643
Product ID 70518-1643_495138c4-c5db-488e-e063-6394a90a8fd9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021519
Listing Expiration 2027-12-31
Marketing Start 2018-10-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181643
Hyphenated Format 70518-1643

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 NDA021519 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BLISTER PACK (70518-1643-0)
source: ndc

Packages (1)

70518-1643-0 30 TABLET, COATED in 1 BLISTER PACK (70518-1643-0)

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": "495138c4-c5db-488e-e063-6394a90a8fd9", "openfda": {"unii": ["5LGN83G74V"], "rxcui": ["903891"], "spl_set_id": ["5198b1c8-8dd6-4b8f-bd85-294ac468af53"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BLISTER PACK (70518-1643-0)", "package_ndc": "70518-1643-0", "marketing_start_date": "20181007"}], "brand_name": "fluvoxamine maleate", "product_id": "70518-1643_495138c4-c5db-488e-e063-6394a90a8fd9", "dosage_form": "TABLET, COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "70518-1643", "generic_name": "Fluvoxamine maleate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluvoxamine maleate", "active_ingredients": [{"name": "FLUVOXAMINE MALEATE", "strength": "50 mg/1"}], "application_number": "NDA021519", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20181007", "listing_expiration_date": "20271231"}