Package 0069-0227-03

Brand: lorbrena

Generic: lorlatinib
NDC Package

Package Facts

Identity

Package NDC 0069-0227-03
Digits Only 0069022703
Product NDC 0069-0227
Description

120 TABLET, FILM COATED in 1 BOTTLE (0069-0227-03)

Marketing

Marketing Status
Marketed Since 2025-01-03
Brand lorbrena
Generic lorlatinib
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "fa9433bd-5ed2-47c3-84cb-f751c1345f81", "openfda": {"nui": ["N0000175605", "N0000175082", "N0000190118", "N0000191264", "N0000187064", "N0000191265", "N0000190111", "N0000191423", "N0000190113"], "upc": ["0300690231013", "0300690227016"], "unii": ["OSP71S83EU"], "rxcui": ["2103169", "2103175", "2103177", "2103179"], "spl_set_id": ["2b34d62d-e02a-4af3-bc0d-1571dd4ee76d"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Kinase Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]", "P-Glycoprotein Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Organic Cation Transporter 1 Inhibitors [MoA]", "Organic Anion Transporter 3 Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0069-0227-01)", "package_ndc": "0069-0227-01", "marketing_start_date": "20181119"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (0069-0227-03)", "package_ndc": "0069-0227-03", "marketing_start_date": "20250103"}], "brand_name": "Lorbrena", "product_id": "0069-0227_fa9433bd-5ed2-47c3-84cb-f751c1345f81", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Organic Anion Transporter 3 Inhibitors [MoA]", "Organic Cation Transporter 1 Inhibitors [MoA]", "P-Glycoprotein Inducers [MoA]"], "product_ndc": "0069-0227", "generic_name": "lorlatinib", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorbrena", "active_ingredients": [{"name": "LORLATINIB", "strength": "25 mg/1"}], "application_number": "NDA210868", "marketing_category": "NDA", "marketing_start_date": "20181119", "listing_expiration_date": "20271231"}