DEA schedule
Is glatiramer acetate a controlled substance?
Federal schedule for glatiramer 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. Glatiramer acetate is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and glatiramer acetate is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 18 prescription listings from 9 labelers, none with a DEA schedule |
| DEA controlled substances list | glatiramer acetate is not on the list |
Glatiramer Acetate NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 68546-317 | Copaxone | injection, solution | 20 mg/mL | Teva Neuroscience, Inc. | None |
| 68546-325 | Copaxone | injection, solution | 40 mg/mL | Teva Neuroscience, Inc. | None |
| 0378-6960 | Glatiramer Acetate | injection, solution | 20 mg/mL | Mylan Pharmaceuticals Inc. | None |
| 0832-6084 | Glatiramer Acetate | injection, solution | 20 mg/mL | UPSHER-SMITH LABORATORIES, LLC | None |
| 11797-764 | GLATIRAMER ACETATE | injection, solution | 20 mg/mL | Italfarmaco SpA | None |
| 47335-990 | Glatiramer Acetate | injection, solution | 20 mg/mL | Sun Pharmaceutical Industries, Inc. | None |
| 70710-1548 | GLATIRAMER ACETATE | injection, solution | 20 mg/mL | Zydus Pharmaceuticals USA Inc. | None |
| 82983-429 | Glatiramer Acetate | injection, solution | 20 mg/mL | AJENAT PHARMACEUTICALS LLC | None |
| 0378-6961 | Glatiramer Acetate | injection, solution | 40 mg/mL | Mylan Pharmaceuticals Inc. | None |
| 0832-6085 | Glatiramer Acetate | injection, solution | 40 mg/mL | UPSHER-SMITH LABORATORIES, LLC | None |
| 11797-765 | GLATIRAMER ACETATE | injection, solution | 40 mg/mL | Italfarmaco SpA | None |
| 47335-991 | Glatiramer Acetate | injection, solution | 40 mg/mL | Sun Pharmaceutical Industries, Inc. | None |
| 70710-1549 | GLATIRAMER ACETATE | injection, solution | 40 mg/mL | Zydus Pharmaceuticals USA Inc. | None |
| 82983-430 | Glatiramer Acetate | injection, solution | 40 mg/mL | AJENAT PHARMACEUTICALS LLC | None |
| 0781-3234 | Glatopa | injection, solution | 20 mg/mL | Sandoz Inc | None |
| 63629-8815 | Glatopa | injection, solution | 20 mg/mL | Bryant Ranch Prepack | None |
| 0781-3250 | Glatopa | injection, solution | 40 mg/mL | Sandoz Inc | None |
| 63629-8816 | Glatopa | injection, solution | 40 mg/mL | Bryant Ranch Prepack | None |
Questions
Is glatiramer acetate a controlled substance?
No. Glatiramer acetate is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and glatiramer acetate is not on the DEA controlled substances list.
Is glatiramer acetate a narcotic?
No. Glatiramer acetate is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic.
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 Glatiramer Acetate
- What is Glatiramer Acetate used for?FDA label uses
- Generic for CopaxoneFDA Orange Book
- What is Copaxone used for?FDA label uses
- Is Copaxone a controlled substance?Federal schedule
- What is Glatopa used for?FDA label uses
- Is Glatopa a controlled substance?Federal schedule
- Glatiramer Acetate Medicare Part D coverageBy plan and state
- NDC 68546-317Glatiramer Acetate NDC record
- NDC 68546-325Glatiramer Acetate NDC record
- NDC 0378-6960Glatiramer Acetate NDC record