Package 64597-301-13

{"route": ["ORAL"], "spl_id": "545d121c-01b2-4375-9067-52fc8ad23d74", "openfda": {"unii": ["9D2RTI9KYH", "J13S2394HE"], "rxcui": ["1040054", "1040058"], "spl_set_id": ["484e0918-3442-49dc-8ccf-177f1f3ee9f3"], "manufacturer_name": ["Avanir Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (64597-301-13)  / 13 CAPSULE, GELATIN COATED in 1 BOTTLE", "package_ndc": "64597-301-13", "marketing_end_date": "20260813", "marketing_start_date": "20101201"}, {"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60)", "package_ndc": "64597-301-60", "marketing_end_date": "20260813", "marketing_start_date": "20101201"}], "brand_name": "NUEDEXTA", "product_id": "64597-301_545d121c-01b2-4375-9067-52fc8ad23d74", "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": "64597-301", "generic_name": "dextromethorphan hydrobromide and quinidine sulfate", "labeler_name": "Avanir Pharmaceuticals, 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": "20101201", "listing_expiration_date": "20261231"}