Package 68382-769-01
Brand: topiramate
Generic: topiramatePackage Facts
Identity
Package NDC
68382-769-01
Digits Only
6838276901
Product NDC
68382-769
Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-769-01)
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": "7d20a70d-017f-48a4-8937-d2c746b5917c", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0368382863065", "0368382358066", "0368382864062"], "unii": ["0H73WJJ391"], "rxcui": ["1436239", "1437278", "1437283", "1437288"], "spl_set_id": ["f72774dd-c7eb-41f9-9837-02baf77cc523"], "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, EXTENDED RELEASE in 1 BOTTLE (68382-769-01)", "package_ndc": "68382-769-01", "marketing_start_date": "20240910"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-769-05)", "package_ndc": "68382-769-05", "marketing_start_date": "20240910"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-769-06)", "package_ndc": "68382-769-06", "marketing_start_date": "20240910"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-769-16)", "package_ndc": "68382-769-16", "marketing_start_date": "20240910"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68382-769-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-769-30)", "package_ndc": "68382-769-78", "marketing_start_date": "20240910"}], "brand_name": "Topiramate", "product_id": "68382-769_7d20a70d-017f-48a4-8937-d2c746b5917c", "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": "68382-769", "generic_name": "Topiramate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "100 mg/1"}], "application_number": "ANDA207382", "marketing_category": "ANDA", "marketing_start_date": "20240910", "listing_expiration_date": "20261231"}