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=ANDA218829"
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
49483-731-41 49483-731 HUMAN OTC DRUG Omeprazole delayed release Omeprazole 20mg TABLET, DELAYED RELEASE ORAL 20251215 N/A ANDA ANDA218829 TIME CAP LABORATORIES, INC. OMEPRAZOLE MAGNESIUM 20 mg/1 3 BOTTLE in 1 CARTON (49483-731-41) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (49483-731-45)
25000-091-77 25000-091 HUMAN OTC DRUG Omeprazole 20 mg Omeprazole 20 mg TABLET, DELAYED RELEASE ORAL 20250812 N/A ANDA ANDA218829 MARKSANS PHARMA LIMITED OMEPRAZOLE MAGNESIUM 20 mg/1 2 BLISTER PACK in 1 CARTON (25000-091-77) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK
25000-091-76 25000-091 HUMAN OTC DRUG Omeprazole 20 mg Omeprazole 20 mg TABLET, DELAYED RELEASE ORAL 20250812 N/A ANDA ANDA218829 MARKSANS PHARMA LIMITED OMEPRAZOLE MAGNESIUM 20 mg/1 1 BOTTLE in 1 CARTON (25000-091-76) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
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