DEA schedule
Is varenicline a controlled substance?
Federal schedule for varenicline from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Varenicline is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and varenicline is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 64 prescription listings from 30 labelers, none with a DEA schedule |
| DEA controlled substances list | varenicline is not on the list |
Varenicline NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 0069-0468 | CHANTIX | tablet, film coated | .5 mg/1 | Pfizer Laboratories Div Pfizer Inc | None |
| 0069-0469 | CHANTIX | tablet, film coated | 1 mg/1 | Pfizer Laboratories Div Pfizer Inc | None |
| 43353-899 | CHANTIX | tablet, film coated | 1 mg/1 | Aphena Pharma Solutions - Tennessee, LLC | None |
| 71205-381 | CHANTIX | tablet, film coated | 1 mg/1 | Proficient Rx LP | None |
| 73521-030 | Tyrvaya | spray | .03 mg/.05mL | Oyster Point Pharma, Inc. | None |
| 60290-077 | VARENICLINE | tablet | .5 mg/1 | Umedica Laboratories USA Inc. | None |
| 60290-078 | VARENICLINE | tablet | 1 mg/1 | Umedica Laboratories USA Inc. | None |
| 0904-7413 | varenicline | tablet, film coated | .5 mg/1 | Major Pharmaceuticals | None |
| 10135-808 | Varenicline | tablet, film coated | .5 mg/1 | Marlex Pharmaceuticals, Inc. | None |
| 27241-173 | Varenicline | tablet, film coated | .5 mg/1 | Ajanta Pharma USA Inc. | None |
| 31722-678 | Varenicline | tablet, film coated | .5 mg/1 | Camber Pharmaceuticals, Inc. | None |
| 33342-489 | Varenicline | tablet, film coated | .5 mg/1 | Macleods Pharmaceuticals Limited | None |
| 42291-927 | varenicline | tablet, film coated | .5 mg/1 | AvKARE | None |
| 49884-155 | Varenicline | tablet, film coated | .5 mg/1 | Par Health USA, LLC | None |
| 50090-6447 | VARENICLINE | tablet, film coated | .5 mg/1 | A-S Medication Solutions | None |
| 50090-7135 | varenicline | tablet, film coated | .5 mg/1 | A-S Medication Solutions | None |
| 50090-8088 | Varenicline | tablet, film coated | .5 mg/1 | A-S Medication Solutions | None |
| 59651-417 | Varenicline | tablet, film coated | .5 mg/1 | Aurobindo Pharma Limited | None |
| 60505-3613 | VARENICLINE | tablet, film coated | .5 mg/1 | Apotex Corp | None |
| 60505-4794 | VARENICLINE | tablet, film coated | .5 mg/1 | Apotex Corp | None |
| 67877-743 | varenicline | tablet, film coated | .5 mg/1 | Ascend Laboratories, LLC | None |
| 70518-4647 | Varenicline | tablet, film coated | .5 mg/1 | REMEDYREPACK INC. | None |
| 70710-1613 | Varenicline | tablet, film coated | .5 mg/1 | Zydus Pharmaceuticals USA Inc. | None |
| 70748-127 | VARENICLINE | tablet, film coated | .5 mg/1 | Lupin Pharmaceuticals, Inc. | None |
| 70771-1773 | Varenicline | tablet, film coated | .5 mg/1 | Zydus Lifesciences Limited | None |
| 72162-2218 | VARENICLINE | tablet, film coated | .5 mg/1 | Bryant Ranch Prepack | None |
| 72603-476 | Varenicline | tablet, film coated | .5 mg/1 | NorthStar RxLLC | None |
| 0904-7414 | varenicline | tablet, film coated | 1 mg/1 | Major Pharmaceuticals | None |
| 10135-809 | Varenicline | tablet, film coated | 1 mg/1 | Marlex Pharmaceuticals, Inc. | None |
| 27241-174 | Varenicline | tablet, film coated | 1 mg/1 | Ajanta Pharma USA Inc. | None |
| 31722-679 | Varenicline | tablet, film coated | 1 mg/1 | Camber Pharmaceuticals, Inc. | None |
| 33342-490 | Varenicline | tablet, film coated | 1 mg/1 | Macleods Pharmaceuticals Limited | None |
| 42291-928 | varenicline | tablet, film coated | 1 mg/1 | AvKARE | None |
| 49884-156 | Varenicline | tablet, film coated | 1 mg/1 | Par Health USA, LLC | None |
| 50090-6446 | VARENICLINE | tablet, film coated | 1 mg/1 | A-S Medication Solutions | None |
| 50090-7182 | varenicline | tablet, film coated | 1 mg/1 | A-S Medication Solutions | None |
| 50090-7997 | VARENICLINE | tablet, film coated | 1 mg/1 | A-S Medication Solutions | None |
| 53401-032 | VARENICLINE | tablet, film coated | 1 mg/1 | Aphena Pharma Solutions - Tennessee, LLC | None |
| 59651-418 | Varenicline | tablet, film coated | 1 mg/1 | Aurobindo Pharma Limited | None |
| 60505-3614 | VARENICLINE | tablet, film coated | 1 mg/1 | Apotex Corp | None |
Showing 40 of 64 listings.
Questions
Is varenicline a controlled substance?
No. Varenicline is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and varenicline is not on the DEA controlled substances list.
Is varenicline a narcotic?
No. Varenicline is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Partial Cholinergic Nicotinic Agonist and Cholinergic 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 Varenicline
- What is Varenicline used for?FDA label uses
- Generic for TyrvayaFDA Orange Book
- Generic for ChantixFDA Orange Book
- What is Tyrvaya used for?FDA label uses
- Is Tyrvaya a controlled substance?Federal schedule
- Partial Cholinergic Nicotinic Agonists listFDA drug class
- Cholinergic Receptor Agonists listFDA drug class
- NDC 0069-0468Varenicline NDC record
- NDC 0069-0469Varenicline NDC record
- NDC 43353-899Varenicline NDC record