美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=NDA019891"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
42858-416-16 42858-416 HUMAN PRESCRIPTION DRUG Dilaudid hydromorphone hydrochloride SOLUTION ORAL 20170515 N/A NDA NDA019891 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 5 mg/5mL 473 mL in 1 BOTTLE, PLASTIC (42858-416-16)
42858-304-16 42858-304 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride SOLUTION ORAL 20120720 N/A NDA AUTHORIZED GENERIC NDA019891 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 5 mg/5mL 473 mL in 1 BOTTLE, PLASTIC (42858-304-16)
60687-566-86 60687-566 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride SOLUTION ORAL 20210930 20251231 NDA AUTHORIZED GENERIC NDA019891 American Health Packaging HYDROMORPHONE HYDROCHLORIDE 5 mg/5mL 3 TRAY in 1 CASE (60687-566-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-566-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-566-40)
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