DEA schedule
Is azelastine a controlled substance?
Federal schedule for azelastine from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Azelastine is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and azelastine is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 20 prescription listings from 16 labelers, none with a DEA schedule |
| DEA controlled substances list | azelastine is not on the list |
Azelastine NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 67877-477 | Azelastine | spray, metered | 137 ug/1 | Ascend Laboratories, LLC | None |
| 46708-506 | AZELASTINE HYDROCHLORIDE | solution/ drops | .5 mg/mL | Alembic Pharmaceuticals Limited | None |
| 47335-938 | Azelastine Hydrochloride | solution/ drops | .5 mg/mL | Sun Pharmaceutical Industries, Inc. | None |
| 60505-0578 | AZELASTINE HYDROCHLORIDE | solution/ drops | .5 mg/mL | Apotex Corp. | None |
| 61314-308 | Azelastine Hydrochloride | solution/ drops | .5 mg/mL | Sandoz Inc | None |
| 68083-287 | Azelastine Hydrochloride | solution/ drops | .5 mg/mL | Gland Pharma Limited | None |
| 70069-091 | Azelastine Hydrochloride | solution/ drops | .5 mg/mL | Somerset Therapeutics, LLC | None |
| 72266-141 | Azelastine Hydrochloride | solution/ drops | .5 mg/mL | Fosun Pharma USA Inc | None |
| 42291-094 | Azelastine Hydrochloride | spray, metered | 1 mg/mL | AvKARE | None |
| 65162-676 | Azelastine Hydrochloride | spray, metered | 1 mg/mL | Amneal Pharmaceuticals LLC | None |
| 47335-779 | Azelastine Hydrochloride | spray, metered | 137 ug/1 | Sun Pharmaceutical Industries, Inc. | None |
| 50090-2330 | Azelastine Hydrochloride | spray, metered | 137 ug/1 | A-S Medication Solutions | None |
| 50090-7461 | AZELASTINE HYDROCHLORIDE | spray, metered | 137 ug/1 | A-S Medication Solutions | None |
| 59651-214 | AZELASTINE HYDROCHLORIDE | spray, metered | 137 ug/1 | Aurobindo Pharma Limited | None |
| 60505-0833 | Azelastine Hydrochloride | spray, metered | 137 ug/1 | Apotex Corp. | None |
| 68788-4056 | Azelastine Hydrochloride | spray, metered | 137 ug/1 | Preferred Pharmaceuticals Inc. | None |
| 68788-8514 | AZELASTINE HYDROCHLORIDE | spray, metered | 137 ug/1 | Preferred Pharmaceuticals Inc. | None |
| 71205-449 | Azelastine Hydrochloride | spray, metered | 137 ug/1 | Proficient Rx LP | None |
| 72603-611 | AZELASTINE HYDROCHLORIDE | spray, metered | 137 ug/1 | NorthStar Rx LLC | None |
| 62332-506 | Azelastine Hydrochloride Ophthalmic Solution 0.05% | solution/ drops | .5 mg/mL | Alembic Pharmaceuticals Inc. | None |
Questions
Is azelastine a controlled substance?
No. Azelastine is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and azelastine is not on the DEA controlled substances list.
Is azelastine a narcotic?
No. Azelastine is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Histamine-1 Receptor 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.