Package 0310-1349-30
Brand: tagrisso
Generic: osimertinibPackage Facts
Identity
Package NDC
0310-1349-30
Digits Only
0310134930
Product NDC
0310-1349
Description
30 TABLET, FILM COATED in 1 BOTTLE (0310-1349-30)
Marketing
Marketing Status
Brand
tagrisso
Generic
osimertinib
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "b4ae37b4-12de-4824-9b06-833e0f18fd38", "openfda": {"nui": ["N0000175605", "N0000175082", "N0000190114", "N0000185506", "N0000191266", "N0000190113"], "unii": ["3C06JJ0Z2O"], "rxcui": ["1721565", "1721571", "1721581", "1721583"], "spl_set_id": ["5e81b4a7-b971-45e1-9c31-29cea8c87ce7"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Kinase Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 1A2 Inducers [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0310-1349-30)", "package_ndc": "0310-1349-30", "marketing_start_date": "20151113"}], "brand_name": "TAGRISSO", "product_id": "0310-1349_b4ae37b4-12de-4824-9b06-833e0f18fd38", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]"], "product_ndc": "0310-1349", "generic_name": "osimertinib", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TAGRISSO", "active_ingredients": [{"name": "OSIMERTINIB", "strength": "40 mg/1"}], "application_number": "NDA208065", "marketing_category": "NDA", "marketing_start_date": "20151113", "listing_expiration_date": "20261231"}