Package 68382-004-16

Brand: topiramate

Generic: topiramate
NDC Package

Package Facts

Identity

Package NDC 68382-004-16
Digits Only 6838200416
Product NDC 68382-004
Description

90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-16)

Marketing

Marketing Status
Marketed Since 2009-10-14
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": "a5fb1350-e27f-43ba-ba26-a28fd3941f8a", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0368382005144"], "unii": ["0H73WJJ391"], "rxcui": ["205315", "205316", "252413"], "spl_set_id": ["e4886adf-199d-4b19-a4ef-75f8f94cb54e"], "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": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-01)", "package_ndc": "68382-004-01", "marketing_start_date": "20091014"}, {"sample": false, "description": "500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-05)", "package_ndc": "68382-004-05", "marketing_start_date": "20091014"}, {"sample": false, "description": "1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-10)", "package_ndc": "68382-004-10", "marketing_start_date": "20091014"}, {"sample": false, "description": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-14)", "package_ndc": "68382-004-14", "marketing_start_date": "20091014"}, {"sample": false, "description": "90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-16)", "package_ndc": "68382-004-16", "marketing_start_date": "20091014"}], "brand_name": "topiramate", "product_id": "68382-004_a5fb1350-e27f-43ba-ba26-a28fd3941f8a", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68382-004", "generic_name": "topiramate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "15 mg/1"}], "application_number": "ANDA078877", "marketing_category": "ANDA", "marketing_start_date": "20091014", "listing_expiration_date": "20261231"}