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Buprenorphine and Naloxone

NDC 0378-8768 · Mylan Pharmaceuticals Inc.

Generic nameBuprenorphine and Naloxone
Dosage formFILM
RouteBUCCAL, SUBLINGUAL
Active ingredient(s)BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE
Strength12; 3 mg/1; mg/1
Pharmacologic classOpioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA scheduleCIII
Marketing categoryANDA

Packages

0378-8768-93 — 30 POUCH in 1 CARTON (0378-8768-93) / 1 FILM in 1 POUCH (0378-8768-16)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

0121-2036 — buprenorphine hydrochloride and naloxone hydrochloride, 0121-2038 — buprenorphine hydrochloride, 0143-9246 — Buprenorphine Hydrochloride, 0228-3153 — Buprenorphine, 0228-3154 — Buprenorphine and Naloxone, 0228-3155 — Buprenorphine and Naloxone, 0228-3156 — Buprenorphine, 0378-8765 — Buprenorphine and Naloxone, 0378-8766 — Buprenorphine and Naloxone, 0378-8767 — Buprenorphine and Naloxone, 0406-7012 — Buprenorphine HCl, 0406-7018 — Buprenorphine HCl, 0406-8005 — Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate, 0406-8020 — Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate, 0409-2012 — Buprenorphine Hydrochloride, 0904-7009 — buprenorphine hydrochloride and naloxone hydrochloride dihydrate, 0904-7010 — buprenorphine hydrochloride and naloxone hydrochloride dihydrate, 0904-7154 — Buprenorphine, 0904-7155 — Buprenorphine, 12496-1202 — buprenorphine hydrochloride, naloxone hydrochloride, +139 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels