DEA schedule

Is acetylcysteine a controlled substance?

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

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

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

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Schedule check

Schedule sources for Acetylcysteine
Source	What it lists
FDA NDC directory	34 prescription listings from 15 labelers, none with a DEA schedule
DEA controlled substances list	acetylcysteine is not on the list

Acetylcysteine NDC listings

NDC listings for Acetylcysteine
NDC	Product	Form	Strength	Labeler	DEA schedule
66220-207	ACETADOTE	injection, solution	200 mg/mL	Cumberland Pharmaceuticals Inc.	None
0517-7504	Acetylcysteine	inhalant	100 mg/mL	American Regent, Inc.	None
0517-7510	Acetylcysteine	inhalant	100 mg/mL	American Regent, Inc.	None
55154-5730	Acetylcysteine	inhalant	100 mg/mL	Cardinal Health 107, LLC	None
0517-7604	Acetylcysteine	inhalant	200 mg/mL	American Regent, Inc.	None
0517-7610	Acetylcysteine	inhalant	200 mg/mL	American Regent, Inc.	None
55154-5731	Acetylcysteine	inhalant	200 mg/mL	Cardinal Health 107, LLC	None
0574-0805	acetylcysteine	injection	200 mg/mL	Padagis US LLC	None
14445-412	ACETYLCYSTEINE	injection	200 mg/mL	Indoco Remedies Limited	None
0143-9433	Acetylcysteine	injection, solution	200 mg/mL	Hikma Pharmaceuticals USA Inc.	None
25021-812	Acetylcysteine	injection, solution	200 mg/mL	Sagent Pharmaceuticals	None
25021-812	Acetylcysteine	injection, solution	200 mg/mL	Sagent Pharmaceuticals	None
63323-963	Acetylcysteine	injection, solution	200 mg/mL	Fresenius Kabi USA, LLC	None
63323-963	Acetylcysteine	injection, solution	200 mg/mL	Fresenius Kabi USA, LLC	None
68462-946	Acetylcysteine	injection, solution	200 mg/mL	Glenmark Pharmaceuticals Inc., USA	None
70069-788	Acetylcysteine	injection, solution	200 mg/mL	Somerset Therapeutics, LLC	None
70594-111	Acetylcysteine	injection, solution	200 mg/mL	Xellia Pharmaceuticals USA LLC	None
83270-001	Acetylcysteine	injection, solution	200 mg/mL	ONESOURCE SPECIALTY PHARMA LIMITED	None
55150-259	Acetylcysteine	injection, solution	6 g/30mL	Eugia US LLC	None
0409-3307	Acetylcysteine	solution	100 mg/mL	Hospira, Inc.	None
42494-435	Acetylcysteine	solution	100 mg/mL	Cameron Pharmaceuticals	None
63323-691	Acetylcysteine	solution	100 mg/mL	Fresenius Kabi USA, LLC	None
63323-693	Acetylcysteine	solution	100 mg/mL	Fresenius Kabi USA, LLC	None
63323-695	Acetylcysteine	solution	100 mg/mL	Fresenius Kabi USA, LLC	None
70069-018	Acetylcysteine	solution	100 mg/mL	Somerset Therapeutics, LLC	None
0409-3308	Acetylcysteine	solution	200 mg/mL	Hospira, Inc.	None
42494-436	Acetylcysteine	solution	200 mg/mL	Cameron Pharmaceuticals	None
63323-690	Acetylcysteine	solution	200 mg/mL	Fresenius Kabi USA, LLC	None
63323-690	Acetylcysteine	solution	200 mg/mL	Fresenius Kabi USA, LLC	None
63323-692	Acetylcysteine	solution	200 mg/mL	Fresenius Kabi USA, LLC	None
63323-694	Acetylcysteine	solution	200 mg/mL	Fresenius Kabi USA, LLC	None
63323-694	Acetylcysteine	solution	200 mg/mL	Fresenius Kabi USA, LLC	None
70069-019	Acetylcysteine	solution	200 mg/mL	Somerset Therapeutics, LLC	None
70069-020	Acetylcysteine	solution	200 mg/mL	Somerset Therapeutics, LLC	None

Questions

Is acetylcysteine a controlled substance?

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

Is acetylcysteine a narcotic?

No. Acetylcysteine is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Antidote and Antidote for Acetaminophen Overdose and Mucolytic.

Does this page cover state schedules?

No. This page reports the federal schedule only. Some states schedule drugs on their own; check your state board of pharmacy.

Is acetylcysteine a controlled substance?

Which 2027 plans near you dropped or restricted acetylcysteine?

Schedule check

Acetylcysteine NDC listings

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