Package 50458-642-65

Brand: topamax

Generic: topiramate
NDC Package

Package Facts

Identity

Package NDC 50458-642-65
Digits Only 5045864265
Product NDC 50458-642
Description

60 TABLET, COATED in 1 BOTTLE (50458-642-65)

Marketing

Marketing Status
Marketed Since 1997-01-01
Brand topamax
Generic topiramate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "24a60ffa-e7bf-4987-8416-a9b8ac82e6ec", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0350458647655", "0350458641653", "0350458645651", "0350458639650", "0350458640656", "0350458642650"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "151227", "151228", "151229", "152855", "199888", "199889", "199890", "205315", "205316", "845478", "845479"], "spl_set_id": ["21628112-0c47-11df-95b3-498d55d89593"], "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": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (50458-642-65)", "package_ndc": "50458-642-65", "marketing_start_date": "19970101"}], "brand_name": "Topamax", "product_id": "50458-642_24a60ffa-e7bf-4987-8416-a9b8ac82e6ec", "dosage_form": "TABLET, COATED", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50458-642", "generic_name": "topiramate", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topamax", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "200 mg/1"}], "application_number": "NDA020505", "marketing_category": "NDA", "marketing_start_date": "19970101", "listing_expiration_date": "20271231"}