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
85534-0004-3	85534-0004	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20250611	N/A	ANDA	ANDA214099	HAWAII REPACK, INC.	BACLOFEN	20 mg/1	30 TABLET in 1 BOTTLE (85534-0004-3)
85534-0004-1	85534-0004	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20250611	N/A	ANDA	ANDA214099	HAWAII REPACK, INC.	BACLOFEN	20 mg/1	120 TABLET in 1 BOTTLE (85534-0004-1)
85534-0004-0	85534-0004	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20250611	N/A	ANDA	ANDA214099	HAWAII REPACK, INC.	BACLOFEN	20 mg/1	100 TABLET in 1 BOTTLE (85534-0004-0)
85534-0004-6	85534-0004	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20250611	N/A	ANDA	ANDA214099	HAWAII REPACK, INC.	BACLOFEN	20 mg/1	60 TABLET in 1 BOTTLE (85534-0004-6)
85534-0004-9	85534-0004	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20250611	N/A	ANDA	ANDA214099	HAWAII REPACK, INC.	BACLOFEN	20 mg/1	90 TABLET in 1 BOTTLE (85534-0004-9)
84386-035-01	84386-035	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20251121	N/A	ANDA	ANDA214099	Aurobindo Pharma Limited	BACLOFEN	5 mg/1	100 TABLET in 1 BOTTLE (84386-035-01)
83008-062-30	83008-062	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20240624	20261231	ANDA	ANDA214099	Quality Care Products, LLC	BACLOFEN	20 mg/1	30 TABLET in 1 BOTTLE (83008-062-30)
83008-062-90	83008-062	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20240521	20270131	ANDA	ANDA214099	Quality Care Products, LLC	BACLOFEN	20 mg/1	90 TABLET in 1 BOTTLE (83008-062-90)
70518-3467-2	70518-3467	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20220928	N/A	ANDA	ANDA214099	REMEDYREPACK INC.	BACLOFEN	20 mg/1	90 TABLET in 1 BOTTLE, PLASTIC (70518-3467-2)
70518-3467-0	70518-3467	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20220805	N/A	ANDA	ANDA214099	REMEDYREPACK INC.	BACLOFEN	20 mg/1	30 TABLET in 1 BOTTLE, PLASTIC (70518-3467-0)
80425-0466-3	80425-0466	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20241228	N/A	ANDA	ANDA214099	Advanced Rx of Tennessee, LLC	BACLOFEN	20 mg/1	90 TABLET in 1 BOTTLE (80425-0466-3)
80425-0467-1	80425-0467	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20241228	N/A	ANDA	ANDA214099	Advanced Rx of Tennessee, LLC	BACLOFEN	20 mg/1	30 TABLET in 1 BOTTLE (80425-0467-1)
80425-0467-2	80425-0467	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20241228	N/A	ANDA	ANDA214099	Advanced Rx of Tennessee, LLC	BACLOFEN	20 mg/1	60 TABLET in 1 BOTTLE (80425-0467-2)
80425-0467-3	80425-0467	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20241228	N/A	ANDA	ANDA214099	Advanced Rx of Tennessee, LLC	BACLOFEN	20 mg/1	90 TABLET in 1 BOTTLE (80425-0467-3)
80425-0467-4	80425-0467	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20241228	N/A	ANDA	ANDA214099	Advanced Rx of Tennessee, LLC	BACLOFEN	20 mg/1	120 TABLET in 1 BOTTLE (80425-0467-4)
80425-0466-4	80425-0466	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20241228	N/A	ANDA	ANDA214099	Advanced Rx of Tennessee, LLC	BACLOFEN	20 mg/1	120 TABLET in 1 BOTTLE (80425-0466-4)
80425-0466-1	80425-0466	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20241228	N/A	ANDA	ANDA214099	Advanced Rx of Tennessee, LLC	BACLOFEN	20 mg/1	30 TABLET in 1 BOTTLE (80425-0466-1)
80425-0466-2	80425-0466	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20241228	N/A	ANDA	ANDA214099	Advanced Rx of Tennessee, LLC	BACLOFEN	20 mg/1	60 TABLET in 1 BOTTLE (80425-0466-2)
68071-3407-3	68071-3407	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20230531	N/A	ANDA	ANDA214099	NuCare Pharmaceuticals,Inc.	BACLOFEN	10 mg/1	3 TABLET in 1 BOTTLE (68071-3407-3)
59651-395-01	59651-395	HUMAN PRESCRIPTION DRUG	BACLOFEN	BACLOFEN	TABLET	ORAL	20210713	N/A	ANDA	ANDA214099	Aurobindo Pharma Limited	BACLOFEN	20 mg/1	100 TABLET in 1 BOTTLE (59651-395-01)