Package 64380-189-01

Brand: zileuton

Generic: zileuton
NDC Package

Package Facts

Identity

Package NDC 64380-189-01
Digits Only 6438018901
Product NDC 64380-189
Description

120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64380-189-01)

Marketing

Marketing Status
Marketed Since 2022-10-15
Brand zileuton
Generic zileuton
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4bb0aa92-80d2-4cbc-9261-012f3b5eb1c1", "openfda": {"nui": ["N0000175956", "N0000175955", "N0000008683"], "upc": ["0364380189015"], "unii": ["V1L22WVE2S"], "rxcui": ["730834"], "spl_set_id": ["a826d16f-df07-447b-b050-b9a02ea1f89e"], "pharm_class_pe": ["Decreased Leukotriene Production [PE]"], "pharm_class_epc": ["5-Lipoxygenase Inhibitor [EPC]"], "pharm_class_moa": ["5-Lipoxygenase Inhibitors [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64380-189-01)", "package_ndc": "64380-189-01", "marketing_start_date": "20221015"}], "brand_name": "Zileuton", "product_id": "64380-189_4bb0aa92-80d2-4cbc-9261-012f3b5eb1c1", "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE", "pharm_class": ["5-Lipoxygenase Inhibitor [EPC]", "5-Lipoxygenase Inhibitors [MoA]", "Decreased Leukotriene Production [PE]"], "product_ndc": "64380-189", "generic_name": "zileuton", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zileuton", "active_ingredients": [{"name": "ZILEUTON", "strength": "600 mg/1"}], "application_number": "ANDA212670", "marketing_category": "ANDA", "marketing_start_date": "20221015", "listing_expiration_date": "20261231"}