FDA.reportPublic FDA data

bupropion hydrobromide 348 MG 24 HR Extended Release Oral Tablet

RxCUI
993567
RxNorm name
bupropion hydrobromide 348 MG 24 HR Extended Release Oral Tablet
Display name
bupropion hydrobromide 348 MG 24 HR Extended Release Oral Tablet
Full name
bupropion hydrobromide 348 MG 24 HR Extended Release Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

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
Bupropion HydrobromideBUPROPION HYDROBROMIDEOceanside Pharmaceuticals3ec04240-baef-44d7-8d73-a181171eec432026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993567
AplenzinBUPROPION HYDROBROMIDEBausch Health US, LLC6494d2d9-0ce4-4126-b1c7-49684395942b2026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993567

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
6494d2d9-0ce4-4126-b1c7-49684395942bbuPROPion HBr 348 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR bupropion hydrobromide 348 MG Extended Release Oral Tablet [SCD] · bupropion hydrobromide 348 MG 24 HR Extended Release Oral Tablet [SY]327These highlights do not include all the information needed to use APLENZIN safely and effectively. See full prescribing information for APLENZIN. APLENZIN ® (bupropion hydrobromide) extended-release tablets, for oral use Initial U.S. Approval: 198520260304
2315d6e5-144d-4163-9711-f855c759cf8ebuPROPion HBr 348 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR bupropion hydrobromide 348 MG Extended Release Oral Tablet [SCD] · bupropion hydrobromide 348 MG 24 HR Extended Release Oral Tablet [SY]31These highlights do not include all the information needed to use APLENZIN safely and effectively. See full prescribing information for APLENZIN. APLENZIN (bupropion hydrobromide) tablet, film coated, extended release for oral use Initial U.S. Approval: 198520110210