Package 0480-2358-01
Brand: topiramate
Generic: topiramatePackage Facts
Identity
Package NDC
0480-2358-01
Digits Only
0480235801
Product NDC
0480-2358
Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2358-01)
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": "38168585-df97-4809-8f00-a61122c7259f", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0304802359565", "0304802356564", "0304802358568", "0304802357561"], "unii": ["0H73WJJ391"], "rxcui": ["1436239", "1437278", "1437283", "1437288"], "spl_set_id": ["4f20155f-05b9-40ec-af34-3b58aa8d60d4"], "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": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2358-01)", "package_ndc": "0480-2358-01", "marketing_start_date": "20230503"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2358-56)", "package_ndc": "0480-2358-56", "marketing_start_date": "20230503"}], "brand_name": "Topiramate", "product_id": "0480-2358_38168585-df97-4809-8f00-a61122c7259f", "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": "0480-2358", "generic_name": "Topiramate", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "100 mg/1"}], "application_number": "ANDA206210", "marketing_category": "ANDA", "marketing_start_date": "20230503", "listing_expiration_date": "20271231"}