Home DailyMed 4c23a34c-e8fc-424c-8fa0-ee064ba6eaef BUPRENORPHINE HYDROCHLORIDE - Food and Drug Administration Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Food and Drug Administration
Effective date 2017-07-06
Label type Indexing - product concept
Version 1
Source full-release
Hydrated at 2026-06-05 00:17:04 Label at a glance# Product BUPRENORPHINE HYDROCHLORIDE
Active ingredient BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 4 matching rows.
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE NALOXONE HYDROCHLORIDE DIHYDRATE NALOXONE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 6 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 9 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join buprenorphine hydrochloride BUPRENORPHINE HYDROCHLORIDE Advagen Pharma Ltd 699638dd-3a53-445f-a545-d0e6eabfe1c9 2026-07-17 Warnings, Adverse reactions Name fallback brand name: buprenorphine hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride BUPRENORPHINE HYDROCHLORIDE REMEDYREPACK INC. 11686845-f5fd-4e96-8a4f-9b132bf48840 2026-07-07 Warnings, Adverse reactions Name fallback brand name: buprenorphine hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride BUPRENORPHINE HYDROCHLORIDE PAI Holdings, LLC dba PAI Pharma 442831cf-9636-433a-9a12-e9a8cd31f72a 2026-02-28 Warnings, Adverse reactions Name fallback brand name: buprenorphine hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE BELBUCA BUPRENORPHINE HYDROCHLORIDE BioDelivery Sciences International Inc bc2b7a3d-72cf-497c-95b0-ba2b71f63c64 2026-01-02 Boxed warning, Warnings, Adverse reactions Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE Buprenorphine Hydrochloride BUPRENORPHINE HYDROCHLORIDE Hospira, Inc. 23aa1bb3-cecf-4e62-29bb-48488bb66fc3 2025-12-31 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Buprenorphine Hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE Buprenorphine Hydrochloride BUPRENORPHINE HYDROCHLORIDE Par Health USA, LLC 34767dda-ce52-4f98-a45f-bb5cee0cd5e6 2025-12-18 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Buprenorphine Hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride BUPRENORPHINE HYDROCHLORIDE A-S Medication Solutions c1398d85-d4bb-4426-8ecf-a50400910d81 2025-05-28 Warnings, Adverse reactions Name fallback brand name: buprenorphine hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE Buprenorphine Hydrochloride BUPRENORPHINE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. adc1167e-910e-4d7b-abdc-751d3df0c3dc 2025-03-13 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Buprenorphine Hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE Buprenorphine Hydrochloride BUPRENORPHINE HYDROCHLORIDE Somerset Therapeutics, LLC 74e40c51-853b-4e7f-b3cb-a27af29e1cbf 2025-02-11 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Buprenorphine Hydrochloride generic name: BUPRENORPHINE HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.