Package 80425-0398-2
Brand: topiramate
Generic: topiramatePackage Facts
Identity
Package NDC
80425-0398-2
Digits Only
8042503982
Product NDC
80425-0398
Description
60 TABLET, FILM COATED in 1 BOTTLE (80425-0398-2)
Marketing
Marketing Status
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": "1a16d6f8-c5e9-d850-e063-6294a90a08cb", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["199889"], "spl_set_id": ["1a16d6a9-3dd1-ede8-e063-6294a90afe75"], "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 (80425-0398-1)", "package_ndc": "80425-0398-1", "marketing_start_date": "20240604"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0398-2)", "package_ndc": "80425-0398-2", "marketing_start_date": "20240604"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0398-3)", "package_ndc": "80425-0398-3", "marketing_start_date": "20240604"}], "brand_name": "topiramate", "product_id": "80425-0398_1a16d6f8-c5e9-d850-e063-6294a90a08cb", "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": "80425-0398", "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": "ANDA078235", "marketing_category": "ANDA", "marketing_start_date": "20240604", "listing_expiration_date": "20261231"}