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）

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
52958-034-01	52958-034	HUMAN PRESCRIPTION DRUG	Bivalirudin	Bivalirudin	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	INTRAVENOUS	20201023	N/A	ANDA	ANDA210031	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	BIVALIRUDIN	250 mg/1	10 VIAL, SINGLE-USE in 1 CARTON (52958-034-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
83634-400-10	83634-400	HUMAN PRESCRIPTION DRUG	Bivalirudin	bivalirudin	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	INTRAVENOUS	20231218	N/A	ANDA	ANDA210031	Avenacy, Inc.	BIVALIRUDIN	250 mg/1	10 VIAL, SINGLE-DOSE in 1 CARTON (83634-400-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-400-41)
70860-402-10	70860-402	HUMAN PRESCRIPTION DRUG	Bivalirudin	bivalirudin	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	INTRAVENOUS	20191130	20250531	ANDA	ANDA210031	Athenex Pharmaceutical Division, LLC.	BIVALIRUDIN	250 mg/1	10 VIAL, SINGLE-DOSE in 1 CARTON (70860-402-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70860-402-41)