DEA schedule

Is baclofen a controlled substance?

Federal schedule for baclofen from the FDA NDC directory, checked against the DEA controlled substances list.

Source: FDA NDC Directory file dated 2026-10-22. Publisher page

No. Baclofen is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and baclofen is not on the DEA controlled substances list.

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Schedule check

Schedule sources for Baclofen
Source	What it lists
FDA NDC directory	233 prescription listings from 65 labelers, none with a DEA schedule
DEA controlled substances list	baclofen is not on the list

Baclofen NDC listings

NDC listings for Baclofen
NDC	Product	Form	Strength	Labeler	DEA schedule
52652-6001	FLEQSUVY	suspension	5 mg/mL	Azurity Pharmaceuticals, Inc.	None
66794-156	Gablofen	injection, solution	1000 ug/mL	Piramal Critical Care Inc	None
66794-157	Gablofen	injection, solution	2000 ug/mL	Piramal Critical Care Inc	None
66794-151	Gablofen	injection, solution	50 ug/mL	Piramal Critical Care Inc	None
66794-155	Gablofen	injection, solution	500 ug/mL	Piramal Critical Care Inc	None
70121-2496	Lioresal (baclofen)	injection	.05 mg/mL	Amneal Pharmaceuticals LLC	None
64896-077	LYVISPAH	granule	10 mg/1	Amneal Pharmaceuticals LLC	None
87519-003	LYVISPAH	granule	10 mg/1	Anvi Pharmaceuticals Inc	None
64896-078	LYVISPAH	granule	20 mg/1	Amneal Pharmaceuticals LLC	None
64896-076	LYVISPAH	granule	5 mg/1	Amneal Pharmaceuticals LLC	None
69528-302	OZOBAX DS	solution	10 mg/5mL	Rosemont Pharmaceuticals LLC	None
70511-123	Baclofen	injection	1000 ug/mL	MAlA Pharmaceuticals, Inc.	None
72888-146	BACLOFEN	injection	1000 ug/mL	Advagen Pharma Limited	None
14789-161	BACLOFEN	injection	2000 ug/mL	Nexus Pharmaceuticals LLC	None
72888-147	BACLOFEN	injection	2000 ug/mL	Advagen Pharma Limited	None
70511-121	Baclofen	injection	50 ug/mL	MAlA Pharmaceuticals, Inc.	None
72888-145	BACLOFEN	injection	500 ug/mL	Advagen Pharma Limited	None
25021-680	Baclofen	injection, solution	1000 ug/mL	Sagent Pharmaceuticals	None
25021-679	Baclofen	injection, solution	2000 ug/mL	Sagent Pharmaceuticals	None
25021-681	Baclofen	injection, solution	50 ug/mL	Sagent Pharmaceuticals	None
25021-678	Baclofen	injection, solution	500 ug/mL	Sagent Pharmaceuticals	None
17856-0620	Baclofen	solution	10 mg/5mL	Atlantic Biologicals Corp.	None
52817-620	Baclofen	solution	10 mg/5mL	TRUPHARMA, LLC	None
68134-403	Baclofen	solution	10 mg/5mL	Palmetto Pharmaceuticals Inc.	None
72888-466	Baclofen	solution	10 mg/5mL	Advagen Pharma Ltd.,	None
72888-103	BACLOFEN	solution	5 mg/5mL	Advagen Pharma Ltd	None
73352-103	BACLOFEN	solution	5 mg/5mL	Trifluent Pharma, LLC	None
52536-600	Baclofen	suspension	5 mg/mL	Wilshire Pharmaceuticals, Inc.	None
62559-204	Baclofen	suspension	5 mg/mL	ANI Pharmaceuticals, Inc.	None
71225-140	BACLOFEN	suspension	5 mg/mL	Slayback Pharma LLC	None
0172-4096	Baclofen	tablet	10 mg/1	Teva Pharmaceuticals USA, Inc.	None
0527-1330	Baclofen	tablet	10 mg/1	Lannett Company, Inc.	None
0603-2406	Baclofen	tablet	10 mg/1	Par Health USA, LLC	None
0615-8466	BACLOFEN	tablet	10 mg/1	NCS HealthCare of KY, LLC dba Vangard Labs	None
0832-1054	Baclofen	tablet	10 mg/1	Upsher-Smith Laboratories, LLC	None
0904-6475	Baclofen	tablet	10 mg/1	Major Pharmaceuticals	None
0904-7552	BACLOFEN	tablet	10 mg/1	Major Pharmaceuticals	None
10135-532	Baclofen	tablet	10 mg/1	Marlex Pharmaceuticals Inc	None
16571-171	BACLOFEN	tablet	10 mg/1	Rising Pharma Holdings, Inc.	None
16714-071	Baclofen	tablet	10 mg/1	Northstar RxLLC	None