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=ANDA209692"
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
65162-039-03 65162-039 HUMAN OTC DRUG Guaifenesin and Dextromethorphan HBr Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20181101 N/A ANDA ANDA209692 Amneal Pharmaceuticals LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60 mg/1; 1200 mg/1 1 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
65162-039-06 65162-039 HUMAN OTC DRUG Guaifenesin and Dextromethorphan HBr Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20181101 N/A ANDA ANDA209692 Amneal Pharmaceuticals LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60 mg/1; 1200 mg/1 1 BOTTLE in 1 CARTON (65162-039-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
65162-039-17 65162-039 HUMAN OTC DRUG Guaifenesin and Dextromethorphan HBr Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20181101 N/A ANDA ANDA209692 Amneal Pharmaceuticals LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60 mg/1; 1200 mg/1 2 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
70677-1050-1 70677-1050 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20230331 N/A ANDA ANDA209692 Strategic Sourcing Services LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30 mg/1; 600 mg/1 20 BLISTER PACK in 1 CARTON (70677-1050-1) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
83324-137-14 83324-137 HUMAN OTC DRUG Mucus Relief DM Guaifenesin Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20240731 N/A ANDA ANDA209692 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60 mg/1; 1200 mg/1 14 BLISTER PACK in 1 CARTON (83324-137-14) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
11822-7340-4 11822-7340 HUMAN OTC DRUG Mucus Relief DM Maximum Strength Guaifenesin, Dextromethorphan HBr TABLET ORAL 20190531 20261231 ANDA ANDA209692 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60 mg/1; 1200 mg/1 42 BLISTER PACK in 1 CARTON (11822-7340-4) / 1 TABLET in 1 BLISTER PACK
0536-1161-34 0536-1161 HUMAN OTC DRUG Mucus Relief DM Extended Release Caplets Guaifenesin, Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20181213 N/A ANDA ANDA209692 Rugby Laboratories, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30 mg/1; 600 mg/1 20 BLISTER PACK in 1 CARTON (0536-1161-34) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
0536-1161-37 0536-1161 HUMAN OTC DRUG Mucus Relief DM Extended Release Caplets Guaifenesin, Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20181213 N/A ANDA ANDA209692 Rugby Laboratories, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30 mg/1; 600 mg/1 40 BLISTER PACK in 1 CARTON (0536-1161-37) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
37808-733-20 37808-733 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20230228 N/A ANDA ANDA209692 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30 mg/1; 600 mg/1 1 BOTTLE, PLASTIC in 1 BOX (37808-733-20) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
37808-733-40 37808-733 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20230228 N/A ANDA ANDA209692 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30 mg/1; 600 mg/1 1 BOTTLE, PLASTIC in 1 BOX (37808-733-40) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
59726-833-20 59726-833 HUMAN OTC DRUG Mucus DM Extended Release Dextromethorphan Hydrobromide and Guaifenesin TABLET ORAL 20190101 20260201 ANDA ANDA209692 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30 mg/1; 600 mg/1 20 BLISTER PACK in 1 CARTON (59726-833-20) / 1 TABLET in 1 BLISTER PACK
72476-734-14 72476-734 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr TABLET ORAL 20191129 N/A ANDA ANDA209692 Care One (Retail Business Services, LLC.) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60 mg/1; 1200 mg/1 14 BLISTER PACK in 1 CARTON (72476-734-14) / 1 TABLET in 1 BLISTER PACK
70000-0464-1 70000-0464 HUMAN OTC DRUG Mucus Relief DM Extended Release Caplets Guaifenesin, Dextromethorphan HBr TABLET ORAL 20181231 N/A ANDA ANDA209692 Cardinal Health (Leader) 70000 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60 mg/1; 1200 mg/1 28 BLISTER PACK in 1 CARTON (70000-0464-1) / 1 TABLET in 1 BLISTER PACK
70000-0464-2 70000-0464 HUMAN OTC DRUG Mucus Relief DM Extended Release Caplets Guaifenesin, Dextromethorphan HBr TABLET ORAL 20181231 N/A ANDA ANDA209692 Cardinal Health (Leader) 70000 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60 mg/1; 1200 mg/1 14 BLISTER PACK in 1 CARTON (70000-0464-2) / 1 TABLET in 1 BLISTER PACK
70000-0491-1 70000-0491 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr TABLET ORAL 20190131 N/A ANDA ANDA209692 Cardinal Health (Leader) 70000 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30 mg/1; 600 mg/1 20 BLISTER PACK in 1 CARTON (70000-0491-1) / 1 TABLET in 1 BLISTER PACK
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