Package 63539-927-01
Brand: lorbrena
Generic: lorlatinibPackage Facts
Identity
Package NDC
63539-927-01
Digits Only
6353992701
Product NDC
63539-927
Description
30 TABLET, FILM COATED in 1 BOTTLE (63539-927-01)
Marketing
Marketing Status
Brand
lorbrena
Generic
lorlatinib
Sample Package
Yes
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "810ce789-bff1-42b9-aef7-1f92f0dde727", "openfda": {"nui": ["N0000175605", "N0000175082", "N0000190118", "N0000191264", "N0000187064", "N0000191265", "N0000190111", "N0000191423", "N0000190113"], "unii": ["OSP71S83EU"], "rxcui": ["2103169", "2103175"], "spl_set_id": ["004f93d7-a1cd-4b67-9207-31cdcb5c5976"], "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": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63539-927-01)", "package_ndc": "63539-927-01", "marketing_start_date": "20230103"}], "brand_name": "Lorbrena", "product_id": "63539-927_810ce789-bff1-42b9-aef7-1f92f0dde727", "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": "63539-927", "generic_name": "lorlatinib", "labeler_name": "U.S. Pharmaceuticals", "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": "20230103", "listing_expiration_date": "20271231"}