Package 80425-0488-2

Brand: topiramate

Generic: topiramate
NDC Package

Package Facts

Identity

Package NDC 80425-0488-2
Digits Only 8042504882
Product NDC 80425-0488
Description

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0488-2)

Marketing

Marketing Status
Marketed Since 2025-01-30
Brand topiramate
Generic topiramate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2cf7a5af-3e85-68de-e063-6394a90a4aa0", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["199889"], "spl_set_id": ["2cf7ce9e-afc2-f94e-e063-6394a90a35d0"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0488-1)", "package_ndc": "80425-0488-1", "marketing_start_date": "20250130"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0488-2)", "package_ndc": "80425-0488-2", "marketing_start_date": "20250130"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0488-3)", "package_ndc": "80425-0488-3", "marketing_start_date": "20250130"}], "brand_name": "topiramate", "product_id": "80425-0488_2cf7a5af-3e85-68de-e063-6394a90a4aa0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "80425-0488", "generic_name": "topiramate", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "100 mg/1"}], "application_number": "ANDA090162", "marketing_category": "ANDA", "marketing_start_date": "20250130", "listing_expiration_date": "20261231"}