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=ANDA078539"
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
76420-916-11 76420-916 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20250128 N/A ANDA ANDA078539 Asclemed USA, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 10 BLISTER PACK in 1 CARTON (76420-916-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK
76420-916-30 76420-916 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20250128 N/A ANDA ANDA078539 Asclemed USA, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (76420-916-30)
54348-819-04 54348-819 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON TABLET, FILM COATED ORAL 20190710 N/A ANDA ANDA078539 PharmPak, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 1 BOTTLE in 1 BOX (54348-819-04) / 4 TABLET, FILM COATED in 1 BOTTLE
54348-819-06 54348-819 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON TABLET, FILM COATED ORAL 20190710 N/A ANDA ANDA078539 PharmPak, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 1 BOTTLE in 1 BOX (54348-819-06) / 6 TABLET, FILM COATED in 1 BOTTLE
54348-819-08 54348-819 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON TABLET, FILM COATED ORAL 20190710 N/A ANDA ANDA078539 PharmPak, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 1 BOTTLE in 1 BOX (54348-819-08) / 8 TABLET, FILM COATED in 1 BOTTLE
61919-565-30 61919-565 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20190822 N/A ANDA ANDA078539 Direct_Rx ONDANSETRON HYDROCHLORIDE 4 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (61919-565-30)
61919-565-45 61919-565 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20190822 N/A ANDA ANDA078539 Direct_Rx ONDANSETRON HYDROCHLORIDE 4 mg/1 45 TABLET, FILM COATED in 1 BOTTLE (61919-565-45)
76420-917-01 76420-917 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20250128 N/A ANDA ANDA078539 Asclemed USA, Inc. ONDANSETRON HYDROCHLORIDE 24 mg/1 1 BLISTER PACK in 1 CARTON (76420-917-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK
85766-053-05 85766-053 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20251001 N/A ANDA ANDA078539 Sportpharm, Inc. dba Sportpharm ONDANSETRON HYDROCHLORIDE 8 mg/1 5 TABLET, FILM COATED in 1 BOTTLE (85766-053-05)
85766-053-10 85766-053 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20251001 N/A ANDA ANDA078539 Sportpharm, Inc. dba Sportpharm ONDANSETRON HYDROCHLORIDE 8 mg/1 10 TABLET, FILM COATED in 1 BOTTLE (85766-053-10)
85766-053-14 85766-053 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20251001 N/A ANDA ANDA078539 Sportpharm, Inc. dba Sportpharm ONDANSETRON HYDROCHLORIDE 8 mg/1 14 TABLET, FILM COATED in 1 BOTTLE (85766-053-14)
76420-916-33 76420-916 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20250128 N/A ANDA ANDA078539 Asclemed USA, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 1 BLISTER PACK in 1 CARTON (76420-916-33) / 3 TABLET, FILM COATED in 1 BLISTER PACK
76420-916-60 76420-916 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20250128 N/A ANDA ANDA078539 Asclemed USA, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 60 TABLET, FILM COATED in 1 BOTTLE (76420-916-60)
76420-916-90 76420-916 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20250128 N/A ANDA ANDA078539 Asclemed USA, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (76420-916-90)
68788-8582-1 68788-8582 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20240212 N/A ANDA ANDA078539 Preferred Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 10 TABLET, FILM COATED in 1 BOTTLE (68788-8582-1)
68788-8582-2 68788-8582 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20240212 N/A ANDA ANDA078539 Preferred Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 12 TABLET, FILM COATED in 1 BOTTLE (68788-8582-2)
68788-8582-3 68788-8582 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20240212 N/A ANDA ANDA078539 Preferred Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (68788-8582-3)
68788-8582-5 68788-8582 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20240212 N/A ANDA ANDA078539 Preferred Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 15 TABLET, FILM COATED in 1 BOTTLE (68788-8582-5)
68788-8582-6 68788-8582 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20240212 N/A ANDA ANDA078539 Preferred Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 60 TABLET, FILM COATED in 1 BOTTLE (68788-8582-6)
57237-076-30 57237-076 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 N/A ANDA ANDA078539 Rising Pharma Holdings, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (57237-076-30)
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