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
68134-401-16	68134-401	HUMAN PRESCRIPTION DRUG	BACLOFEN	Baclofen	SOLUTION	ORAL	20220315	N/A	NDA AUTHORIZED GENERIC	NDA208193	Palmetto Pharmaceuticals Inc.	BACLOFEN	5 mg/5mL	473 mL in 1 BOTTLE (68134-401-16)
68134-403-16	68134-403	HUMAN PRESCRIPTION DRUG	Baclofen	Baclofen	SOLUTION	ORAL	20240925	N/A	NDA AUTHORIZED GENERIC	NDA208193	Palmetto Pharmaceuticals Inc.	BACLOFEN	10 mg/5mL	473 mL in 1 BOTTLE (68134-403-16)
52817-620-08	52817-620	HUMAN PRESCRIPTION DRUG	Baclofen	Baclofen	SOLUTION	ORAL	20231012	N/A	NDA AUTHORIZED GENERIC	NDA208193	TRUPHARMA, LLC	BACLOFEN	10 mg/5mL	237 mL in 1 BOTTLE (52817-620-08)
72834-602-16	72834-602	HUMAN PRESCRIPTION DRUG	Baclofen	Baclofen	SOLUTION	ORAL	20240305	N/A	NDA AUTHORIZED GENERIC	NDA208193	Sarras Health LLC	BACLOFEN	10 mg/5mL	473 mL in 1 BOTTLE (72834-602-16)
69528-302-08	69528-302	HUMAN PRESCRIPTION DRUG	OZOBAX DS	Baclofen	SOLUTION	ORAL	20231012	N/A	NDA	NDA208193	Metacel Pharmaceuticals, LLC	BACLOFEN	10 mg/5mL	237 mL in 1 BOTTLE (69528-302-08)
69528-302-16	69528-302	HUMAN PRESCRIPTION DRUG	OZOBAX DS	Baclofen	SOLUTION	ORAL	20231012	N/A	NDA	NDA208193	Metacel Pharmaceuticals, LLC	BACLOFEN	10 mg/5mL	473 mL in 1 BOTTLE (69528-302-16)