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=BLA125122"
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
0006-4047-20 0006-4047 VACCINE RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent SOLUTION ORAL 20060203 N/A BLA BLA125122 Merck Sharp & Dohme LLC HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN 2200000 [iU]/2mL; 2800000 [iU]/2mL; 2200000 [iU]/2mL; 2000000 [iU]/2mL; 2300000 [iU]/2mL 25 POUCH in 1 CARTON (0006-4047-20) / 1 TUBE in 1 POUCH (0006-4047-02) / 2 mL in 1 TUBE (0006-4047-01)
0006-4047-41 0006-4047 VACCINE RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent SOLUTION ORAL 20060203 N/A BLA BLA125122 Merck Sharp & Dohme LLC HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN 2200000 [iU]/2mL; 2800000 [iU]/2mL; 2200000 [iU]/2mL; 2000000 [iU]/2mL; 2300000 [iU]/2mL 10 POUCH in 1 CARTON (0006-4047-41) / 1 TUBE in 1 POUCH (0006-4047-02) / 2 mL in 1 TUBE (0006-4047-01)
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