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=ANDA083312"
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
0641-6082-25 0641-6082 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 N/A ANDA ANDA083312 Hikma Pharmaceuticals USA Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL 25 AMPULE in 1 CARTON (0641-6082-25) / 1 mL in 1 AMPULE (0641-6082-01)
0641-6083-25 0641-6083 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 N/A ANDA ANDA083312 Hikma Pharmaceuticals USA Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/mL 25 AMPULE in 1 CARTON (0641-6083-25) / 1 mL in 1 AMPULE (0641-6083-01)
0641-6084-25 0641-6084 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 N/A ANDA ANDA083312 Hikma Pharmaceuticals USA Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL 25 VIAL in 1 CARTON (0641-6084-25) / 1 mL in 1 VIAL (0641-6084-01)
0641-6085-25 0641-6085 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 N/A ANDA ANDA083312 Hikma Pharmaceuticals USA Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/mL 25 VIAL in 1 CARTON (0641-6085-25) / 1 mL in 1 VIAL (0641-6085-01)
0641-6208-25 0641-6208 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 N/A ANDA ANDA083312 Hikma Pharmaceuticals USA Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL 25 VIAL in 1 CARTON (0641-6208-25) / 1 mL in 1 VIAL (0641-6208-01)
52584-495-31 52584-495 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 20240630 ANDA ANDA083312 General Injectables & Vaccines, Inc PROMETHAZINE HYDROCHLORIDE 25 mg/mL 1 AMPULE in 1 BAG (52584-495-31) / 1 mL in 1 AMPULE
52584-496-31 52584-496 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 20100801 20240531 ANDA ANDA083312 General Injectables & Vaccines, Inc PROMETHAZINE HYDROCHLORIDE 50 mg/mL 1 AMPULE in 1 BAG (52584-496-31) / 1 mL in 1 AMPULE
0404-9940-01 0404-9940 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20220113 N/A ANDA ANDA083312 Henry Schein, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9940-01) / 1 mL in 1 VIAL, SINGLE-DOSE
0404-9941-01 0404-9941 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20220117 N/A ANDA ANDA083312 Henry Schein, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL 1 AMPULE in 1 BAG (0404-9941-01) / 1 mL in 1 AMPULE
0404-9942-01 0404-9942 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR 20220117 N/A ANDA ANDA083312 Henry Schein, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/mL 1 AMPULE in 1 BAG (0404-9942-01) / 1 mL in 1 AMPULE
51662-1247-1 51662-1247 HUMAN PRESCRIPTION DRUG PROMETHAZINE HCI PROMETHAZINE HCI INJECTION INTRAMUSCULAR; INTRAVENOUS 20180826 N/A ANDA ANDA083312 HF Acquisition Co. LLC, DBA HealthFirst PROMETHAZINE HYDROCHLORIDE 25 mg/mL 1 mL in 1 VIAL, SINGLE-DOSE (51662-1247-1)
51662-1247-3 51662-1247 HUMAN PRESCRIPTION DRUG PROMETHAZINE HCI PROMETHAZINE HCI INJECTION INTRAMUSCULAR; INTRAVENOUS 20201027 N/A ANDA ANDA083312 HF Acquisition Co. LLC, DBA HealthFirst PROMETHAZINE HYDROCHLORIDE 25 mg/mL 25 POUCH in 1 CASE (51662-1247-3) / 1 mL in 1 POUCH (51662-1247-2)
51662-1248-1 51662-1248 HUMAN PRESCRIPTION DRUG PROMETHAZINE HCI PROMETHAZINE HCI INJECTION INTRAMUSCULAR; INTRAVENOUS 20180826 N/A ANDA ANDA083312 HF Acquisition Co. LLC, DBA HealthFirst PROMETHAZINE HYDROCHLORIDE 50 mg/mL 1 mL in 1 AMPULE (51662-1248-1)
51662-1248-3 51662-1248 HUMAN PRESCRIPTION DRUG PROMETHAZINE HCI PROMETHAZINE HCI INJECTION INTRAMUSCULAR; INTRAVENOUS 20180826 N/A ANDA ANDA083312 HF Acquisition Co. LLC, DBA HealthFirst PROMETHAZINE HYDROCHLORIDE 50 mg/mL 25 POUCH in 1 CASE (51662-1248-3) / 1 AMPULE in 1 POUCH (51662-1248-2) / 1 mL in 1 AMPULE
71872-7077-1 71872-7077 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20180305 N/A ANDA ANDA083312 Medical Purchasing Solutions, LLC PROMETHAZINE HYDROCHLORIDE 25 mg/mL 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7077-1) / 1 mL in 1 VIAL, SINGLE-DOSE
70518-2656-0 70518-2656 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20200325 N/A ANDA ANDA083312 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/mL 25 VIAL in 1 CARTON (70518-2656-0) / 1 mL in 1 VIAL (70518-2656-1)
55154-2861-5 55154-2861 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 N/A ANDA ANDA083312 Cardinal Health 107, LLC PROMETHAZINE HYDROCHLORIDE 25 mg/mL 5 VIAL, SINGLE-DOSE in 1 BAG (55154-2861-5) / 1 mL in 1 VIAL, SINGLE-DOSE
71872-7285-1 71872-7285 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20220329 N/A ANDA ANDA083312 Medical Purchasing Solutions, LLC PROMETHAZINE HYDROCHLORIDE 25 mg/mL 1 AMPULE in 1 BAG (71872-7285-1) / 1 mL in 1 AMPULE
50090-0879-0 50090-0879 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR 20141128 N/A ANDA ANDA083312 A-S Medication Solutions PROMETHAZINE HYDROCHLORIDE 50 mg/mL 25 VIAL, SINGLE-DOSE in 1 PACKAGE (50090-0879-0) / 1 mL in 1 VIAL, SINGLE-DOSE
0641-0928-25 0641-0928 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 N/A ANDA ANDA083312 Hikma Pharmaceuticals USA Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL 25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-0928-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-0928-21)
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