Package 68382-138-16

Brand: topiramate

Generic: topiramate
NDC Package

Package Facts

Identity

Package NDC 68382-138-16
Digits Only 6838213816
Product NDC 68382-138
Description

90 TABLET, FILM COATED in 1 BOTTLE (68382-138-16)

Marketing

Marketing Status
Marketed Since 2009-03-27
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": "970d3fcf-0744-47c3-8a88-706956e9ea21", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0368382139146", "0368382141149", "0368382138149", "0368382140142"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199888", "199889", "199890"], "spl_set_id": ["67dcdd6e-48bc-418e-a887-805929d83ce0"], "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 TABLET, FILM COATED in 1 BOTTLE (68382-138-01)", "package_ndc": "68382-138-01", "marketing_start_date": "20090327"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68382-138-05)", "package_ndc": "68382-138-05", "marketing_start_date": "20090327"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68382-138-14)", "package_ndc": "68382-138-14", "marketing_start_date": "20090327"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-138-16)", "package_ndc": "68382-138-16", "marketing_start_date": "20090327"}], "brand_name": "topiramate", "product_id": "68382-138_970d3fcf-0744-47c3-8a88-706956e9ea21", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68382-138", "generic_name": "topiramate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "ANDA078235", "marketing_category": "ANDA", "marketing_start_date": "20090327", "listing_expiration_date": "20261231"}