Package 10370-368-01

Brand: topiramate

Generic: topiramate
NDC Package

Package Facts

Identity

Package NDC 10370-368-01
Digits Only 1037036801
Product NDC 10370-368
Description

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-368-01)

Marketing

Marketing Status
Marketed Since 2023-03-24
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": "d2a47bf0-9716-4318-9f8c-bd3d43c0637f", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0310370368113"], "unii": ["0H73WJJ391"], "rxcui": ["1437288"], "spl_set_id": ["9ac09563-5967-498c-93ae-675a7f4efc48"], "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 (10370-368-01)", "package_ndc": "10370-368-01", "marketing_start_date": "20230324"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-368-11)", "package_ndc": "10370-368-11", "marketing_start_date": "20230324"}], "brand_name": "Topiramate", "product_id": "10370-368_d2a47bf0-9716-4318-9f8c-bd3d43c0637f", "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": "10370-368", "generic_name": "Topiramate", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "200 mg/1"}], "application_number": "ANDA205976", "marketing_category": "ANDA", "marketing_start_date": "20230324", "listing_expiration_date": "20261231"}