FDA.reportPublic FDA data

Aplenzin 522 MG 24HR Extended Release Oral Tablet

RxCUI
993683
RxNorm name
Aplenzin 522 MG 24HR Extended Release Oral Tablet
Display name
Aplenzin 522 MG 24HR Extended Release Oral Tablet
Full name
Aplenzin 522 MG 24HR Extended Release Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AplenzinBUPROPION HYDROBROMIDEBausch Health US, LLC6494d2d9-0ce4-4126-b1c7-49684395942b2026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993683

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
6494d2d9-0ce4-4126-b1c7-49684395942bAplenzin 522 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR bupropion hydrobromide 522 MG Extended Release Oral Tablet [Aplenzin] [SBD] · 24 HR Aplenzin 522 MG Extended Release Oral Tablet [SY] · Aplenzin 522 MG 24 HR Extended Release Oral Tablet [SY]427These 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