DEA schedule
Is Lybalvi a controlled substance?
Lybalvi contains olanzapine and samidorphan l-malate. Federal schedule from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Lybalvi (olanzapine and samidorphan l-malate) is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and olanzapine and samidorphan l-malate is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 4 prescription listings from 1 labelers, none with a DEA schedule |
| DEA controlled substances list | olanzapine and samidorphan l-malate is not on the list |
Lybalvi NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 65757-652 | LYBALVI | tablet, film coated | 10 mg/1; 10 mg/1 | Alkermes, Inc. | None |
| 65757-653 | LYBALVI | tablet, film coated | 15 mg/1; 10 mg/1 | Alkermes, Inc. | None |
| 65757-654 | LYBALVI | tablet, film coated | 20 mg/1; 10 mg/1 | Alkermes, Inc. | None |
| 65757-651 | LYBALVI | tablet, film coated | 5 mg/1; 10 mg/1 | Alkermes, Inc. | None |
Questions
Is Lybalvi a controlled substance?
No. Lybalvi (olanzapine and samidorphan l-malate) is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and olanzapine and samidorphan l-malate is not on the DEA controlled substances list.
Is Lybalvi a narcotic?
No. Lybalvi (olanzapine and samidorphan l-malate) is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Atypical Antipsychotic and 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.