Package 53746-553-05
Brand: metaxalone
Generic: metaxalonePackage Facts
Identity
Package NDC
53746-553-05
Digits Only
5374655305
Product NDC
53746-553
Description
500 TABLET in 1 BOTTLE (53746-553-05)
Marketing
Marketing Status
Brand
metaxalone
Generic
metaxalone
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "b3ba9f93-52d6-4287-9e28-92059e0bf18b", "openfda": {"nui": ["N0000175730", "N0000175737"], "upc": ["0353746553300"], "unii": ["1NMA9J598Y"], "rxcui": ["351254"], "spl_set_id": ["f06f2b96-3684-483c-89f7-6c9201fd4664"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-553-01)", "package_ndc": "53746-553-01", "marketing_start_date": "20130531"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-553-05)", "package_ndc": "53746-553-05", "marketing_start_date": "20130531"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (53746-553-30)", "package_ndc": "53746-553-30", "marketing_start_date": "20130531"}], "brand_name": "Metaxalone", "product_id": "53746-553_b3ba9f93-52d6-4287-9e28-92059e0bf18b", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]"], "product_ndc": "53746-553", "generic_name": "Metaxalone", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metaxalone", "active_ingredients": [{"name": "METAXALONE", "strength": "800 mg/1"}], "application_number": "ANDA203399", "marketing_category": "ANDA", "marketing_start_date": "20130531", "listing_expiration_date": "20261231"}