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Buprenorphine and Naloxone

NDC 43598-579 · Dr.Reddys Laboratories Inc

Generic nameBuprenorphine and Naloxone
Dosage formFILM, SOLUBLE
RouteBUCCAL, SUBLINGUAL
Active ingredient(s)BUPRENORPHINE HYDROCHLORIDE, NALOXONE
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

43598-579-30 — 30 POUCH in 1 CARTON (43598-579-30) / 1 FILM, SOLUBLE in 1 POUCH (43598-579-01)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

31722-871 — Buprenorphine HCl, 3215-6521 — buprenorphine and naloxone, 3215-6522 — buprenorphine and naloxone, 3215-6523 — buprenorphine and naloxone, 3215-6524 — buprenorphine and naloxone, 42023-179 — Buprenorphine Hydrochloride, 42858-501 — BUPRENORPHINE, 42858-502 — BUPRENORPHINE, 42858-601 — Buprenorphine and Naloxone, 42858-602 — Buprenorphine and Naloxone, 43598-580 — Buprenorphine and Naloxone, 43598-581 — Buprenorphine and Naloxone, 43598-582 — Buprenorphine and Naloxone, 47781-355 — Buprenorphine and Naloxone, 47781-356 — Buprenorphine and Naloxone, 47781-357 — Buprenorphine and Naloxone, 47781-358 — Buprenorphine and Naloxone, 50090-5805 — BUPRENORPHINE, 50090-7559 — buprenorphine hydrochloride, 50268-128 — Buprenorphine, +143 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