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Buprenorphine HCl and Naloxone HCl

NDC 65162-416 · Amneal Pharmaceuticals LLC

Generic nameBuprenorphine and Naloxone
Dosage formTABLET
RouteSUBLINGUAL
Active ingredient(s)BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE
Strength2; .5 mg/1; mg/1
Pharmacologic classOpioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA scheduleCIII
Marketing categoryANDA

Packages

65162-416-03 — 30 TABLET in 1 BOTTLE (65162-416-03)

65162-416-09 — 90 TABLET in 1 BOTTLE (65162-416-09)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

62756-459 — Buprenorphine, 62756-460 — Buprenorphine, 62756-969 — Buprenorphine and Naloxone, 62756-970 — Buprenorphine and Naloxone, 63629-5074 — Buprenorphine and Naloxone, 63629-7269 — Buprenorphine and Naloxone, 63629-9475 — BUPRENORPHINE, 63629-9482 — Buprenorphine and Naloxone, 63629-9483 — Buprenorphine and Naloxone, 65162-415 — Buprenorphine and Naloxone, 67296-1933 — Buprenorphine and Naloxone, 67296-2063 — Buprenorphine and Naloxone, 67296-2123 — Buprenorphine HCl, 67296-2164 — Buprenorphine and Naloxone, 67296-2173 — Buprenorphine, 67296-2191 — BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE, 67296-2228 — buprenorphine and naloxone, 67877-606 — BUPRENORPHINE AND NALOXONE, 67877-607 — BUPRENORPHINE AND NALOXONE, 70069-027 — Buprenorphine 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