Package 0078-0109-01
Brand: sandimmune
Generic: cyclosporinePackage Facts
Identity
Package NDC
0078-0109-01
Digits Only
0078010901
Product NDC
0078-0109
Description
10 AMPULE in 1 BOX (0078-0109-01) / 5 mL in 1 AMPULE (0078-0109-61)
Marketing
Marketing Status
Brand
sandimmune
Generic
cyclosporine
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "a95916e5-4d66-4009-a36c-9ca9e6ce6867", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["197552", "197553", "205175", "212810", "212844", "212957", "309632", "328160"], "spl_set_id": ["5e5926a7-1de0-4b54-a5c0-286b6200ff82"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 BOX (0078-0109-01) / 5 mL in 1 AMPULE (0078-0109-61)", "package_ndc": "0078-0109-01", "marketing_start_date": "19831114"}], "brand_name": "Sandimmune", "product_id": "0078-0109_a95916e5-4d66-4009-a36c-9ca9e6ce6867", "dosage_form": "INJECTION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0078-0109", "generic_name": "cyclosporine", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sandimmune", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "50 mg/mL"}], "application_number": "NDA050573", "marketing_category": "NDA", "marketing_start_date": "19831114", "listing_expiration_date": "20261231"}