FDA.reportPublic FDA data

buprenorphine 0.7 MG / naloxone 0.18 MG Sublingual Tablet [Zubsolv]

RxCUI
1864414
RxNorm name
buprenorphine 0.7 MG / naloxone 0.18 MG Sublingual Tablet [Zubsolv]
Display name
buprenorphine 0.7 MG / naloxone 0.18 MG Sublingual Tablet [Zubsolv]
Full name
buprenorphine 0.7 MG / naloxone 0.18 MG Sublingual Tablet [Zubsolv]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:00

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZubsolvBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEdenbridge Pharmaceuticals LLC.57583c1d-9c44-4503-917d-68dba7377bd12026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 1864414
ZubsolvBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEOrexo US, Inc.5f5cfcfe-d52b-49e6-8fe4-550477332dd22025-12-27Warnings, Adverse reactionsExact identifier
rxcui: 1864414

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
5f5cfcfe-d52b-49e6-8fe4-550477332dd2Zubsolv 0.7 MG / 0.18 MG Sublingual Tablet [PSN] · buprenorphine 0.7 MG / naloxone 0.18 MG Sublingual Tablet [Zubsolv] [SBD] · Zubsolv 0.7 MG / 0.18 MG Sublingual Tablet [SY]327These highlights do not include all the information needed to use ZUBSOLV ® safely and effectively. See full prescribing information for ZUBSOLV. ZUBSOLV (buprenorphine and naloxone sublingual tablets), CIII Initial U.S. Approval: 200220251227