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=ANDA209215"
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
71610-499-53 71610-499 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20201120 N/A ANDA ANDA209215 Aphena Pharma Solutions - Tennessee, LLC GUAIFENESIN 600 mg/1 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-53)
71610-499-12 71610-499 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20210416 N/A ANDA ANDA209215 Aphena Pharma Solutions - Tennessee, LLC GUAIFENESIN 600 mg/1 12 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-12)
36800-226-16 36800-226 HUMAN OTC DRUG Topco Mucus Relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20210601 N/A ANDA ANDA209215 Topco Associates, LLC GUAIFENESIN 600 mg/1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (36800-226-16)
79903-271-40 79903-271 HUMAN OTC DRUG Guaifenesin Extended Release 600 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20241022 N/A ANDA ANDA209215 Wal-Mart Stores, Inc. GUAIFENESIN 600 mg/1 2 BLISTER PACK in 1 CARTON (79903-271-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
0904-6986-40 0904-6986 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20190923 N/A ANDA ANDA209215 Major Pharmaceuticals GUAIFENESIN 600 mg/1 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-6986-40)
53943-234-07 53943-234 HUMAN OTC DRUG Mucus Relief Max Guaifenesin TABLET, EXTENDED RELEASE ORAL 20250214 N/A ANDA ANDA209215 Discount Drug Mart, Inc GUAIFENESIN 1200 mg/1 1 BLISTER PACK in 1 CARTON (53943-234-07) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
53943-233-32 53943-233 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20250213 N/A ANDA ANDA209215 Discount Drug Mart, Inc GUAIFENESIN 600 mg/1 2 BLISTER PACK in 1 CARTON (53943-233-32) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
53041-234-47 53041-234 HUMAN OTC DRUG Guaifenesin Extended-Release 1200 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20180301 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 1200 mg/1 6 BLISTER PACK in 1 CARTON (53041-234-47) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
53041-190-20 53041-190 HUMAN OTC DRUG Mucus Relief 600 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20200624 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 600 mg/1 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-190-20)
53041-190-32 53041-190 HUMAN OTC DRUG Mucus Relief 600 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20200624 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 600 mg/1 2 BLISTER PACK in 1 CARTON (53041-190-32) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
53041-190-38 53041-190 HUMAN OTC DRUG Mucus Relief 600 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20200624 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 600 mg/1 4 BLISTER PACK in 1 CARTON (53041-190-38) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
53041-191-37 53041-191 HUMAN OTC DRUG Mucus Relief Maximum Strength 1200 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20240430 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 1200 mg/1 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-191-37)
53041-191-48 53041-191 HUMAN OTC DRUG Mucus Relief Maximum Strength 1200 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20200624 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 1200 mg/1 4 BLISTER PACK in 1 CARTON (53041-191-48) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
53041-191-58 53041-191 HUMAN OTC DRUG Mucus Relief Maximum Strength 1200 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20200624 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 1200 mg/1 2 BLISTER PACK in 1 CARTON (53041-191-58) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
53041-191-62 53041-191 HUMAN OTC DRUG Mucus Relief Maximum Strength 1200 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20240430 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 1200 mg/1 70 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-191-62)
53041-234-58 53041-234 HUMAN OTC DRUG Guaifenesin Extended-Release 1200 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20180301 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 1200 mg/1 2 BLISTER PACK in 1 CARTON (53041-234-58) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
53041-233-30 53041-233 HUMAN OTC DRUG Guaifenesin Extended-Release 600 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20180301 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 600 mg/1 1 BLISTER PACK in 1 CARTON (53041-233-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
53041-233-32 53041-233 HUMAN OTC DRUG Guaifenesin Extended-Release 600 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20180301 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 600 mg/1 2 BLISTER PACK in 1 CARTON (53041-233-32) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
53041-233-38 53041-233 HUMAN OTC DRUG Guaifenesin Extended-Release 600 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20180301 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 600 mg/1 4 BLISTER PACK in 1 CARTON (53041-233-38) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
53041-234-37 53041-234 HUMAN OTC DRUG Guaifenesin Extended-Release 1200 mg Guaifenesin TABLET, EXTENDED RELEASE ORAL 20180301 N/A ANDA ANDA209215 Guardian Drug Company GUAIFENESIN 1200 mg/1 4 BLISTER PACK in 1 CARTON (53041-234-37) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
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