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）

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
76420-335-04	76420-335	HUMAN PRESCRIPTION DRUG	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	SOLUTION	ORAL	20250422	N/A	NDA AUTHORIZED GENERIC	NDA011265	Asclemed USA, Inc.	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15 mg/5mL; 6.25 mg/5mL	118 mL in 1 BOTTLE (76420-335-04)
76420-335-16	76420-335	HUMAN PRESCRIPTION DRUG	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	SOLUTION	ORAL	20250422	N/A	NDA AUTHORIZED GENERIC	NDA011265	Asclemed USA, Inc.	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15 mg/5mL; 6.25 mg/5mL	473 mL in 1 BOTTLE (76420-335-16)
62559-758-04	62559-758	HUMAN PRESCRIPTION DRUG	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	SOLUTION	ORAL	20240905	N/A	NDA AUTHORIZED GENERIC	NDA011265	ANI Pharmaceuticals, Inc.	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15 mg/5mL; 6.25 mg/5mL	118 mL in 1 BOTTLE (62559-758-04)
62559-758-16	62559-758	HUMAN PRESCRIPTION DRUG	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	SOLUTION	ORAL	20240905	N/A	NDA AUTHORIZED GENERIC	NDA011265	ANI Pharmaceuticals, Inc.	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15 mg/5mL; 6.25 mg/5mL	473 mL in 1 BOTTLE (62559-758-16)