Package 10370-367-01

Brand: topiramate

Generic: topiramate
NDC Package

Package Facts

Identity

Package NDC 10370-367-01
Digits Only 1037036701
Product NDC 10370-367
Description

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-367-01)

Marketing

Marketing Status
Marketed Since 2023-05-24
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": "f7bcb5d1-262e-4d6b-8eb9-50d55a292dfc", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0310370365112", "0310370367116", "0310370366119"], "unii": ["0H73WJJ391"], "rxcui": ["1436239", "1437278", "1437283"], "spl_set_id": ["11e0924b-fbee-4ec4-b1e4-22d7683b21ee"], "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": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-367-01)", "package_ndc": "10370-367-01", "marketing_start_date": "20230524"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-367-11)", "package_ndc": "10370-367-11", "marketing_start_date": "20230524"}], "brand_name": "Topiramate", "product_id": "10370-367_f7bcb5d1-262e-4d6b-8eb9-50d55a292dfc", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "10370-367", "generic_name": "Topiramate", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "100 mg/1"}], "application_number": "ANDA205976", "marketing_category": "ANDA", "marketing_start_date": "20230524", "listing_expiration_date": "20261231"}