Package 59148-053-16

{"route": ["ORAL"], "spl_id": "b73848d5-ceb2-482a-99bd-a2b6b895abae", "openfda": {"unii": ["9D2RTI9KYH", "J13S2394HE"], "rxcui": ["1040054", "1040058"], "spl_set_id": ["c8cce784-8c5f-415b-8068-76e5d481d159"], "manufacturer_name": ["Otsuka America Pharmaceutical, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16)", "package_ndc": "59148-053-16", "marketing_start_date": "20230103"}, {"sample": false, "description": "4 CARTON in 1 BOX (59148-053-98)  / 1 BOTTLE in 1 CARTON (59148-053-07)  / 13 CAPSULE, GELATIN COATED in 1 BOTTLE", "package_ndc": "59148-053-98", "marketing_start_date": "20230103"}], "brand_name": "Nuedexta", "product_id": "59148-053_b73848d5-ceb2-482a-99bd-a2b6b895abae", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Antiarrhythmic [EPC]", "Cytochrome P450 2D6 Inhibitor [EPC]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "59148-053", "generic_name": "dextromethorphan hydrobromide and quinidine sulfate", "labeler_name": "Otsuka America Pharmaceutical, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nuedexta", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "QUINIDINE SULFATE", "strength": "10 mg/1"}], "application_number": "NDA021879", "marketing_category": "NDA", "marketing_start_date": "20230103", "listing_expiration_date": "20271231"}