DEA schedule

Is buprenorphine and naloxone a controlled substance?

Federal schedule for buprenorphine and naloxone from the FDA NDC directory, checked against the DEA controlled substances list.

Source: FDA NDC Directory file dated 2026-10-22. Publisher page

Yes. Buprenorphine and naloxone is a Schedule III controlled substance under the federal Controlled Substances Act. Matching DEA list entry: Buprenorphine (Schedule III).

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Schedule check

Schedule sources for Buprenorphine and Naloxone
SourceWhat it lists
FDA NDC directory104 prescription listings from 29 labelers, all Schedule III
DEA controlled substances listBuprenorphine: Schedule III

DEA list entry

DEA list entries for buprenorphine and naloxone
SubstanceDEA codeScheduleNarcoticOther namesMatch
Buprenorphine9064IIIYesBuprenex; Temgesic; Subutex; SuboxoneListed by name

Buprenorphine and Naloxone NDC listings

NDC listings for Buprenorphine and Naloxone
NDCProductFormStrengthLabelerDEA schedule
12496-1212Suboxonefilm, soluble12 mg/1; 3 mg/1INDIVIOR INC.CIII
12496-1202Suboxonefilm, soluble2 mg/1; .5 mg/1INDIVIOR INC.CIII
12496-1204Suboxonefilm, soluble4 mg/1; 1 mg/1INDIVIOR INC.CIII
12496-1208Suboxonefilm, soluble8 mg/1; 2 mg/1INDIVIOR INC.CIII
54123-907Zubsolvtablet, orally disintegrating.7 mg/1; .18 mg/1Orexo US, Inc.CIII
82111-201Zubsolvtablet, orally disintegrating.7 mg/1; .18 mg/1Edenbridge Pharmaceuticals LLC.CIII
54123-914Zubsolvtablet, orally disintegrating1.4 mg/1; .36 mg/1Orexo US, Inc.CIII
82111-202Zubsolvtablet, orally disintegrating1.4 mg/1; .36 mg/1Edenbridge Pharmaceuticals LLC.CIII
54123-114Zubsolvtablet, orally disintegrating11.4 mg/1; 2.9 mg/1Orexo US, Inc.CIII
82111-206Zubsolvtablet, orally disintegrating11.4 mg/1; 2.9 mg/1Edenbridge Pharmaceuticals LLC.CIII
54123-929Zubsolvtablet, orally disintegrating2.9 mg/1; .71 mg/1Orexo US, Inc.CIII
82111-203Zubsolvtablet, orally disintegrating2.9 mg/1; .71 mg/1Edenbridge Pharmaceuticals LLC.CIII
54123-957Zubsolvtablet, orally disintegrating5.7 mg/1; 1.4 mg/1Orexo US, Inc.CIII
82111-204Zubsolvtablet, orally disintegrating5.7 mg/1; 1.4 mg/1Edenbridge Pharmaceuticals LLC.CIII
54123-986Zubsolvtablet, orally disintegrating8.6 mg/1; 2.1 mg/1Orexo US, Inc.CIII
82111-205Zubsolvtablet, orally disintegrating8.6 mg/1; 2.1 mg/1Edenbridge Pharmaceuticals LLC.CIII
0378-8768Buprenorphine and Naloxonefilm12 mg/1; 3 mg/1Mylan Pharmaceuticals Inc.CIII
3215-6524Buprenorphine and Naloxonefilm12 mg/1; 3 mg/1Aveva Drug Delivery Systems Inc.CIII
47781-358Buprenorphine and Naloxone Sublingual Filmfilm12 mg/1; 3 mg/1Alvogen Inc.CIII
50742-365Buprenorphine and Naloxonefilm12 mg/1; 3 mg/1INGENUS PHARMACEUTICALS, LLCCIII
0378-8765Buprenorphine and Naloxonefilm2 mg/1; .5 mg/1Mylan Pharmaceuticals Inc.CIII
3215-6521Buprenorphine and Naloxonefilm2 mg/1; .5 mg/1Aveva Drug Delivery Systems Inc.CIII
47781-355Buprenorphine and Naloxone Sublingual Filmfilm2 mg/1; .5 mg/1Alvogen Inc.CIII
50742-397Buprenorphine and Naloxonefilm2 mg/1; .5 mg/1INGENUS PHARMACEUTICALS, LLCCIII
67296-2063Buprenorphine and Naloxonefilm2 mg/1; .5 mg/1Redpharm DrugCIII
67296-2228Buprenorphine and Naloxonefilm2 mg/1; .5 mg/1Redpharm DrugCIII
0378-8766Buprenorphine and Naloxonefilm4 mg/1; 1 mg/1Mylan Pharmaceuticals Inc.CIII
3215-6522Buprenorphine and Naloxonefilm4 mg/1; 1 mg/1Aveva Drug Delivery Systems Inc.CIII
47781-356Buprenorphine and Naloxone Sublingual Filmfilm4 mg/1; 1 mg/1Alvogen Inc.CIII
50742-398Buprenorphine and Naloxonefilm4 mg/1; 1 mg/1INGENUS PHARMACEUTICALS, LLCCIII
0378-8767Buprenorphine and Naloxonefilm8 mg/1; 2 mg/1Mylan Pharmaceuticals Inc.CIII
3215-6523Buprenorphine and Naloxonefilm8 mg/1; 2 mg/1Aveva Drug Delivery Systems Inc.CIII
47781-357Buprenorphine and Naloxone Sublingual Filmfilm8 mg/1; 2 mg/1Alvogen Inc.CIII
50742-364Buprenorphine and Naloxonefilm8 mg/1; 2 mg/1INGENUS PHARMACEUTICALS, LLCCIII
67296-1933Buprenorphine and Naloxone Sublingual Filmfilm8 mg/1; 2 mg/1Redpharm DrugCIII
67296-1933Buprenorphine and Naloxone Sublingual Filmfilm8 mg/1; 2 mg/1Redpharm DrugCIII
67296-1933Buprenorphine and Naloxone Sublingual Filmfilm8 mg/1; 2 mg/1Redpharm DrugCIII
31722-482Buprenorphine and Naloxonefilm, soluble12 mg/1; 3 mg/1Camber Pharmaceuticals, Inc.CIII
43598-581Buprenorphine and Naloxonefilm, soluble12 mg/1; 3 mg/1Dr.Reddys Laboratories IncCIII
31722-479Buprenorphine and Naloxonefilm, soluble2 mg/1; .5 mg/1Camber Pharmaceuticals, Inc.CIII

Showing 40 of 104 listings.

Questions

Is buprenorphine and naloxone a controlled substance?

Yes. Buprenorphine and naloxone is a Schedule III controlled substance under the federal Controlled Substances Act. Matching DEA list entry: Buprenorphine (Schedule III).

Is buprenorphine and naloxone a narcotic?

Yes. The DEA list marks buprenorphine and naloxone as a narcotic (NARC = Y) and places it in Schedule III. Its FDA established pharmacologic class is Opioid Antagonist and Partial Opioid Agonist.

What schedule is buprenorphine and naloxone?

Buprenorphine and naloxone is Schedule III in the FDA NDC directory, which matches the DEA controlled substances list.

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.

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