DEA schedule
Is naloxone a controlled substance?
Federal schedule for naloxone from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Naloxone is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and naloxone is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 72 prescription listings from 32 labelers, none with a DEA schedule |
| DEA controlled substances list | naloxone is not on the list |
Naloxone NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 59467-679 | KLOXXADO | spray | 8 mg/.1mL | Hikma Specialty USA Inc. | None |
| 60842-002 | Naloxone Hydrochloride Injection, USP, Auto-Injector | injection, solution | 10 mg/.4mL | Kaleo, Inc. | None |
| 50090-2422 | NARCAN | spray | 4 mg/.1mL | A-S Medication Solutions | None |
| 69547-353 | Narcan | spray | 4 mg/.1mL | Emergent Devices Inc. | None |
| 71205-528 | Narcan | spray | 4 mg/.1mL | Proficient Rx LP | None |
| 51662-1240 | NARCAN NALOXONE HCI | spray | 4 mg/.1mL | HF Acquisition Co LLC, DBA HealthFirst | None |
| 76329-3669 | REXTOVY | spray | 4 mg/.25mL | International Medication Systems, Ltd. | None |
| 83245-003 | REZENOPY | spray | 10 mg/.11mL | Scienture LLC | None |
| 84571-140 | ZIMHI | injection, solution | 5 mg/.5mL | ZMI Pharma Inc. | None |
| 51662-1242 | NALOXONE HCI | injection, solution | .4 mg/mL | HF Acquisition Co. LLC, DBA Health First | None |
| 51662-1620 | NALOXONE HCl | spray | 4 mg/.1mL | HF Acquisition Co LLC, DBA HealthFirst | None |
| 50090-5908 | Naloxone Hydrochloride | inhalant | 4 mg/.1mL | A-S Medication Solutions | None |
| 0641-6132 | Naloxone Hydrochloride | injection | .4 mg/mL | Hikma Pharmaceuticals USA Inc. | None |
| 0641-6193 | Naloxone Hydrochloride | injection | .4 mg/mL | Hikma Pharmaceuticals USA Inc. | None |
| 0641-6260 | Naloxone Hydrochloride | injection | .4 mg/mL | Hikma Pharmaceuticals USA Inc. | None |
| 51662-1671 | NALOXONE HYDROCHLORIDE | injection | .4 mg/mL | HF Acquisition Co LLC, DBA HealthFirst | None |
| 71872-7009 | Naloxone Hydrochloride | injection | .4 mg/mL | Medical Purchasing Solutions, LLC | None |
| 72572-450 | Naloxone Hydrochloride | injection | .4 mg/mL | Civica, Inc. | None |
| 0404-9922 | NALOXONE HYDROCHLORIDE | injection | 1 mg/mL | Henry Schein, Inc | None |
| 0641-6205 | Naloxone Hydrochloride | injection | 1 mg/mL | Hikma Pharmaceuticals USA Inc. | None |
| 42023-224 | Naloxone Hydrochloride | injection | 1 mg/mL | Par Health USA, LLC | None |
| 43598-750 | Naloxone Hydrochloride | injection | 1 mg/mL | Dr. Reddy's Laboratories, Inc. | None |
| 51662-1239 | NALOXONE HYDROCHLORIDE | injection | 1 mg/mL | HF Acquisition Co. LLC, DBA HealthFirst | None |
| 51662-1529 | NALOXONE HYDROCHLORIDE | injection | 1 mg/mL | HF Acquisition Co LLC, DBA HealthFirst | None |
| 51662-1690 | NALOXONE HYDROCHLORIDE | injection | 1 mg/mL | HF Acquisition Co LLC, DBA HealthFirst | None |
| 70518-2725 | Naloxone Hydrochloride | injection | 1 mg/mL | REMEDYREPACK INC. | None |
| 71872-7177 | Naloxone Hydrochloride | injection | 1 mg/mL | Medical Purchasing Solutions, LLC | None |
| 71872-7294 | Naloxone Hydrochloride | injection | 1 mg/mL | Medical Purchasing Solutions, LLC | None |
| 76329-1469 | Naloxone Hydrochloride | injection | 1 mg/mL | International Medication Systems, Limited | None |
| 76329-3369 | Naloxone Hydrochloride | injection | 1 mg/mL | International Medication Systems, Limited | None |
| 76329-3469 | Naloxone Hydrochloride | injection | 1 mg/mL | International Medication Systems, Limited | None |
| 0404-9773 | NALOXONE HYDROCHLORIDE | injection, solution | .4 mg/mL | Henry Schein, Inc. | None |
| 0404-9920 | Naloxone Hydrochloride | injection, solution | .4 mg/mL | Henry Schein, Inc. | None |
| 0409-1215 | Naloxone Hydrochloride | injection, solution | .4 mg/mL | Hospira, Inc. | None |
| 0409-1219 | Naloxone Hydrochloride | injection, solution | .4 mg/mL | Hospira, Inc. | None |
| 0409-1782 | Naloxone Hydrochloride | injection, solution | .4 mg/mL | Hospira, Inc. | None |
| 36000-308 | naloxone hydrochloride | injection, solution | .4 mg/mL | Baxter Healthcare Corporation | None |
| 36000-310 | NALOXONE HYDROCHLORIDE | injection, solution | .4 mg/mL | Baxter Healthcare Corporation | None |
| 50090-5427 | Naloxone Hydrochloride | injection, solution | .4 mg/mL | A-S Medication Solutions | None |
| 50090-6491 | Naloxone Hydrochloride | injection, solution | .4 mg/mL | A-S Medication Solutions | None |
Showing 40 of 72 listings.
Questions
Is naloxone a controlled substance?
No. Naloxone is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and naloxone is not on the DEA controlled substances list.
Is naloxone a narcotic?
No. Naloxone is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Opioid Antagonist.
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.
More on Naloxone
- What is Naloxone used for?FDA label uses
- Generic for NarcanFDA Orange Book
- Generic for ZimhiFDA Orange Book
- Generic for KloxxadoFDA Orange Book
- Generic for RezenopyFDA Orange Book
- What is Narcan used for?FDA label uses
- Is Narcan a controlled substance?Federal schedule
- Opioid Antagonists listFDA drug class
- NDC 50090-2422Naloxone NDC record
- NDC 51662-1240Naloxone NDC record
- NDC 59467-679Naloxone NDC record