Package 68992-3010-3

{"route": ["ORAL"], "spl_id": "163c129d-f4e2-484d-af96-c265c9a5e38c", "openfda": {"upc": ["0368992304033", "0368992301032", "0368992307539", "0368992301018", "0368992307515"], "unii": ["WM0HAQ4WNM"], "rxcui": ["1664434", "1664440", "1664456", "1664458", "1664461", "1664463"], "spl_set_id": ["de2315b0-6344-43ac-9aea-3e3b68d828e7"], "manufacturer_name": ["Veloxis Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (68992-3010-1)  / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "68992-3010-1", "marketing_start_date": "20150901"}, {"sample": false, "description": "1 POUCH in 1 CARTON (68992-3010-3)  / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "68992-3010-3", "marketing_start_date": "20150901"}], "brand_name": "Envarsus XR", "product_id": "68992-3010_163c129d-f4e2-484d-af96-c265c9a5e38c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]"], "product_ndc": "68992-3010", "generic_name": "Tacrolimus", "labeler_name": "Veloxis Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Envarsus", "brand_name_suffix": "XR", "active_ingredients": [{"name": "TACROLIMUS", "strength": "1 mg/1"}], "application_number": "NDA206406", "marketing_category": "NDA", "marketing_start_date": "20150901", "listing_expiration_date": "20261231"}