DEA schedule
Is leuprolide acetate a controlled substance?
Federal schedule for leuprolide acetate from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Leuprolide acetate is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and leuprolide acetate is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 10 prescription listings from 3 labelers, none with a DEA schedule |
| DEA controlled substances list | leuprolide acetate is not on the list |
Leuprolide Acetate NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 62935-227 | Eligard | injection, suspension, extended release | 22.5 mg/.375mL | TOLMAR Inc. | None |
| 62935-306 | Eligard | injection, suspension, extended release | 30 mg/.5mL | TOLMAR Inc. | None |
| 62935-461 | Eligard | injection, suspension, extended release | 45 mg/.375mL | TOLMAR Inc. | None |
| 62935-756 | Eligard | injection, suspension, extended release | 7.5 mg/.25mL | TOLMAR Inc. | None |
| 62935-163 | Fensolvi | injection, suspension, extended release | 45 mg/.375mL | TOLMAR Inc. | None |
| 42023-259 | LEUPROLIDE ACETATE | injection | 1 mg/.2mL | Endo USA, Inc. | None |
| 85043-025 | Vabrinty | injection, suspension, extended release | 22.5 mg/.375mL | URONOVA PHARMACEUTICALS, INC. | None |
| 85043-030 | Vabrinty | injection, suspension, extended release | 30 mg/.5mL | URONOVA PHARMACEUTICALS, INC. | None |
| 85043-045 | Vabrinty | injection, suspension, extended release | 45 mg/.375mL | URONOVA PHARMACEUTICALS, INC. | None |
| 85043-075 | Vabrinty | injection, suspension, extended release | 7.5 mg/.25mL | URONOVA PHARMACEUTICALS, INC. | None |
Questions
Is leuprolide acetate a controlled substance?
No. Leuprolide acetate is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and leuprolide acetate is not on the DEA controlled substances list.
Is leuprolide acetate a narcotic?
No. Leuprolide acetate is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Gonadotropin Releasing Hormone 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 Leuprolide Acetate
- What is Leuprolide Acetate used for?FDA label uses
- Generic for Lupron DepotFDA Orange Book
- Generic for Lupron Depot-ped KitFDA Orange Book
- Generic for Eligard KitFDA Orange Book
- Generic for Fensolvi KitFDA Orange Book
- Generic for LupronFDA Orange Book
- Gonadotropin Releasing Hormone Receptor Agonists listFDA drug class
- NDC 62935-163Leuprolide Acetate NDC record
- NDC 62935-227Leuprolide Acetate NDC record
- NDC 62935-306Leuprolide Acetate NDC record