Package 69117-0048-3

Brand: lamotrigine

Generic: lamotrigine extended-release
NDC Package

Package Facts

Identity

Package NDC 69117-0048-3
Digits Only 6911700483
Product NDC 69117-0048
Description

500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0048-3)

Marketing

Marketing Status
Marketed Since 2021-12-09
Brand lamotrigine
Generic lamotrigine extended-release
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "47239426-3d75-73d8-e063-6294a90a608d", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0369117004920", "0369117004739", "0369117004517", "0369117004913", "0369117004425", "0369117004722", "0369117004838", "0369117004418", "0369117004616", "0369117004623", "0369117004715", "0369117004432", "0369117004524", "0369117004814", "0369117004821", "0369117004630", "0369117004937", "0369117004531"], "unii": ["U3H27498KS"], "rxcui": ["850087", "850091", "900156", "900164", "1098608", "1146690"], "spl_set_id": ["f7de11a5-5357-4753-b1ac-b15123b50028"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]"], "pharm_class_moa": ["Organic Cation Transporter 2 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitors [MoA]"], "manufacturer_name": ["Yiling Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0048-1)", "package_ndc": "69117-0048-1", "marketing_start_date": "20211209"}, {"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0048-2)", "package_ndc": "69117-0048-2", "marketing_start_date": "20211209"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0048-3)", "package_ndc": "69117-0048-3", "marketing_start_date": "20211209"}], "brand_name": "lamotrigine", "product_id": "69117-0048_47239426-3d75-73d8-e063-6294a90a608d", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Dihydrofolate Reductase Inhibitors [MoA]", "Mood Stabilizer [EPC]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "product_ndc": "69117-0048", "generic_name": "lamotrigine extended-release", "labeler_name": "Yiling Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "250 mg/1"}], "application_number": "ANDA213949", "marketing_category": "ANDA", "marketing_start_date": "20211209", "listing_expiration_date": "20261231"}