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BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE

NDC 16729-549 · Accord Healthcare, Inc

Generic nameBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
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

16729-549-10 — 30 TABLET in 1 BOTTLE, PLASTIC (16729-549-10)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

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, 12496-1204 — buprenorphine hydrochloride, naloxone hydrochloride, 12496-1208 — buprenorphine hydrochloride, naloxone hydrochloride, 12496-1212 — buprenorphine hydrochloride, naloxone hydrochloride, 16729-550 — BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE, 31722-479 — buprenorphine and naloxone, 31722-480 — buprenorphine and naloxone, 31722-481 — buprenorphine and naloxone, 31722-482 — buprenorphine and naloxone, 31722-850 — Buprenorphine and Naloxone, 31722-851 — Buprenorphine and Naloxone, 31722-870 — Buprenorphine HCl, 31722-871 — Buprenorphine HCl, 3215-6521 — buprenorphine and naloxone, +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