DEA schedule
Is Mounjaro a controlled substance?
Mounjaro contains tirzepatide. 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. Mounjaro (tirzepatide) is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and tirzepatide is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 30 prescription listings from 2 labelers, none with a DEA schedule |
| DEA controlled substances list | tirzepatide is not on the list |
Mounjaro NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 0002-1471 | Mounjaro | injection, solution | 10 mg/.5mL | Eli Lilly and Company | None |
| 0002-2340 | Mounjaro | injection, solution | 10 mg/.5mL | Eli Lilly and Company | None |
| 50090-8021 | MOUNJARO | injection, solution | 10 mg/.5mL | A-S Medication Solutions | None |
| 0002-1460 | Mounjaro | injection, solution | 12.5 mg/.5mL | Eli Lilly and Company | None |
| 0002-2423 | Mounjaro | injection, solution | 12.5 mg/.5mL | Eli Lilly and Company | None |
| 50090-8022 | MOUNJARO | injection, solution | 12.5 mg/.5mL | A-S Medication Solutions | None |
| 0002-3444 | Mounjaro KwikPen | injection, solution | 12.5 mg/mL | Eli Lilly and Company | None |
| 0002-4210 | Mounjaro | injection, solution | 12.5 mg/mL | Eli Lilly and Company | None |
| 0002-1457 | Mounjaro | injection, solution | 15 mg/.5mL | Eli Lilly and Company | None |
| 0002-3002 | Mounjaro | injection, solution | 15 mg/.5mL | Eli Lilly and Company | None |
| 50090-8026 | MOUNJARO | injection, solution | 15 mg/.5mL | A-S Medication Solutions | None |
| 0002-3433 | Mounjaro KwikPen | injection, solution | 16.7 mg/mL | Eli Lilly and Company | None |
| 0002-4304 | Mounjaro | injection, solution | 16.7 mg/mL | Eli Lilly and Company | None |
| 0002-1152 | Mounjaro | injection, solution | 2.5 mg/.5mL | Eli Lilly and Company | None |
| 0002-1506 | Mounjaro | injection, solution | 2.5 mg/.5mL | Eli Lilly and Company | None |
| 50090-8025 | MOUNJARO | injection, solution | 2.5 mg/.5mL | A-S Medication Solutions | None |
| 0002-3422 | Mounjaro KwikPen | injection, solution | 20.8 mg/mL | Eli Lilly and Company | None |
| 0002-4523 | Mounjaro | injection, solution | 20.8 mg/mL | Eli Lilly and Company | None |
| 0002-3411 | Mounjaro KwikPen | injection, solution | 25 mg/mL | Eli Lilly and Company | None |
| 0002-4612 | Mounjaro | injection, solution | 25 mg/mL | Eli Lilly and Company | None |
| 0002-3466 | Mounjaro KwikPen | injection, solution | 4.17 mg/mL | Eli Lilly and Company | None |
| 0002-4052 | Mounjaro | injection, solution | 4.17 mg/mL | Eli Lilly and Company | None |
| 0002-1243 | Mounjaro | injection, solution | 5 mg/.5mL | Eli Lilly and Company | None |
| 0002-1495 | Mounjaro | injection, solution | 5 mg/.5mL | Eli Lilly and Company | None |
| 50090-8024 | MOUNJARO | injection, solution | 5 mg/.5mL | A-S Medication Solutions | None |
| 0002-1484 | Mounjaro | injection, solution | 7.5 mg/.5mL | Eli Lilly and Company | None |
| 0002-2214 | Mounjaro | injection, solution | 7.5 mg/.5mL | Eli Lilly and Company | None |
| 50090-8023 | MOUNJARO | injection, solution | 7.5 mg/.5mL | A-S Medication Solutions | None |
| 0002-3455 | Mounjaro KwikPen | injection, solution | 8.33 mg/mL | Eli Lilly and Company | None |
| 0002-4103 | Mounjaro | injection, solution | 8.33 mg/mL | Eli Lilly and Company | None |
Questions
Is Mounjaro a controlled substance?
No. Mounjaro (tirzepatide) is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and tirzepatide is not on the DEA controlled substances list.
Is Mounjaro a narcotic?
No. Mounjaro (tirzepatide) is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is GLP-1 Receptor Agonist and Glucose-dependent Insulinotropic Polypeptide Receptor Agonist.
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 Mounjaro
- What is Mounjaro used for?FDA label uses
- Generic for MounjaroFDA Orange Book
- Generic for Mounjaro (autoinjector)FDA Orange Book
- Generic for Mounjaro KwikpenFDA Orange Book
- Generic for ZepboundFDA Orange Book
- Generic for Zepbound (autoinjector)FDA Orange Book
- Generic for Zepbound KwikpenFDA Orange Book
- GLP-1 Receptor Agonists listFDA drug class
- Glucose-dependent Insulinotropic Polypeptide Receptor Agonists listFDA drug class
- Mounjaro Medicare Part D coverageBy plan and state
- NDC 0002-1152Mounjaro NDC record
- NDC 0002-1243Mounjaro NDC record
- NDC 0002-1457Mounjaro NDC record