Package 80425-0495-1

Brand: topiramate

Generic: topiramate
NDC Package

Package Facts

Identity

Package NDC 80425-0495-1
Digits Only 8042504951
Product NDC 80425-0495
Description

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0495-1)

Marketing

Marketing Status
Marketed Since 2025-03-20
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": "30ca2fd3-12e0-364f-e063-6394a90a0638", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["151226"], "spl_set_id": ["30ca2fce-4e4c-439e-e063-6294a90af076"], "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 (80425-0495-1)", "package_ndc": "80425-0495-1", "marketing_start_date": "20250320"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0495-2)", "package_ndc": "80425-0495-2", "marketing_start_date": "20250320"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0495-3)", "package_ndc": "80425-0495-3", "marketing_start_date": "20250320"}], "brand_name": "topiramate", "product_id": "80425-0495_30ca2fd3-12e0-364f-e063-6394a90a0638", "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": "80425-0495", "generic_name": "topiramate", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "50 mg/1"}], "application_number": "ANDA090162", "marketing_category": "ANDA", "marketing_start_date": "20250320", "listing_expiration_date": "20261231"}