Package 82804-022-90

Brand: lamotrigine

Generic: lamotrigine extended-release
NDC Package

Package Facts

Identity

Package NDC 82804-022-90
Digits Only 8280402290
Product NDC 82804-022
Description

90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-90)

Marketing

Marketing Status
Marketed Since 2023-10-11
Brand lamotrigine
Generic lamotrigine extended-release
Sample Package No

Linked Drug Pages (0)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "39efe933-bfed-4a6a-b270-0883871c5186", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0382804022304"], "unii": ["U3H27498KS"], "rxcui": ["850091"], "spl_set_id": ["39efe933-bfed-4a6a-b270-0883871c5186"], "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": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-30)", "package_ndc": "82804-022-30", "marketing_start_date": "20231011"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-60)", "package_ndc": "82804-022-60", "marketing_start_date": "20231011"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-90)", "package_ndc": "82804-022-90", "marketing_start_date": "20231011"}], "brand_name": "lamotrigine", "product_id": "82804-022_39efe933-bfed-4a6a-b270-0883871c5186", "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": "82804-022", "generic_name": "lamotrigine extended-release", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "50 mg/1"}], "application_number": "ANDA213949", "marketing_category": "ANDA", "marketing_start_date": "20211209", "listing_expiration_date": "20261231"}