Package 72974-415-01

{"route": ["ORAL"], "spl_id": "d0b51ef8-0118-4b78-a83f-73338d6dab9b", "openfda": {"nui": ["N0000175839", "N0000175084", "N0000008638", "N0000190118", "N0000187064", "N0000190113", "N0000185503"], "upc": ["0372974415013"], "unii": ["CXY7B3Q98Z", "9S44LIC7OJ", "P76B05O5V6"], "rxcui": ["2556799", "2556800"], "spl_set_id": ["fc3feb73-cc84-43a8-aa32-b262460495e8"], "pharm_class_pe": ["Decreased GnRH Secretion [PE]"], "pharm_class_epc": ["Gonadotropin Releasing Hormone Receptor Antagonist [EPC]"], "pharm_class_moa": ["Gonadotropin Releasing Hormone Receptor Antagonists [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Sumitomo Pharma America, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01)", "package_ndc": "72974-415-01", "marketing_start_date": "20210526"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99)", "package_ndc": "72974-415-99", "marketing_start_date": "20210707"}], "brand_name": "Myfembree", "product_id": "72974-415_d0b51ef8-0118-4b78-a83f-73338d6dab9b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Decreased GnRH Secretion [PE]", "Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Gonadotropin Releasing Hormone Receptor Antagonist [EPC]", "Gonadotropin Releasing Hormone Receptor Antagonists [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "72974-415", "generic_name": "relugolix, estradiol hemihydrate, and norethindrone acetate", "labeler_name": "Sumitomo Pharma America, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Myfembree", "active_ingredients": [{"name": "ESTRADIOL HEMIHYDRATE", "strength": "1 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".5 mg/1"}, {"name": "RELUGOLIX", "strength": "40 mg/1"}], "application_number": "NDA214846", "marketing_category": "NDA", "marketing_start_date": "20210526", "listing_expiration_date": "20261231"}