Package 61269-380-12

{"route": ["ORAL"], "spl_id": "07e2c55d-707f-4e3f-be0e-385da673b8ee", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["R3O80H60KX", "140QMO216E", "P6R62377KV"], "rxcui": ["1294619", "1294621"], "spl_set_id": ["5cdacbf5-67be-42eb-bd54-8acc32ea1abc"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["H2-Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BOX (61269-380-12)  / 12 CAPSULE in 1 BLISTER PACK", "package_ndc": "61269-380-12", "marketing_start_date": "20231001"}], "brand_name": "PYLERA", "product_id": "61269-380_07e2c55d-707f-4e3f-be0e-385da673b8ee", "dosage_form": "CAPSULE", "pharm_class": ["Bismuth [CS]", "Bismuth [EPC]", "Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]", "Tetracycline-class Antimicrobial [EPC]", "Tetracyclines [CS]"], "product_ndc": "61269-380", "generic_name": "BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, and TETRACYCLINE HYDROCHLORIDE", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PYLERA", "active_ingredients": [{"name": "BISMUTH SUBCITRATE POTASSIUM", "strength": "140 mg/1"}, {"name": "METRONIDAZOLE", "strength": "125 mg/1"}, {"name": "TETRACYCLINE HYDROCHLORIDE", "strength": "125 mg/1"}], "application_number": "NDA050786", "marketing_category": "NDA", "marketing_start_date": "20231001", "listing_expiration_date": "20261231"}