FDA.reportPublic FDA data

Aplenzin 348 MG 24 HR Extended Release Oral Tablet

RxCUI
993569
RxNorm name
Aplenzin 348 MG 24 HR Extended Release Oral Tablet
Display name
Aplenzin 348 MG 24 HR Extended Release Oral Tablet
Full name
Aplenzin 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 · 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: 993569

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
6494d2d9-0ce4-4126-b1c7-49684395942bAplenzin 348 MG 24 HR Extended Release Oral TabletSY27These 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
6494d2d9-0ce4-4126-b1c7-49684395942b24 HR Aplenzin 348 MG Extended Release Oral TabletSY27These 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
6494d2d9-0ce4-4126-b1c7-49684395942b24 HR bupropion hydrobromide 348 MG Extended Release Oral Tablet [Aplenzin]SBD27These 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
6494d2d9-0ce4-4126-b1c7-49684395942bAplenzin 348 MG 24HR Extended Release Oral TabletPSN27These 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-f855c759cf8eAplenzin 348 MG 24HR Extended Release Oral TabletPSN1These 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
2315d6e5-144d-4163-9711-f855c759cf8eAplenzin 348 MG 24 HR Extended Release Oral TabletSY1These 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
2315d6e5-144d-4163-9711-f855c759cf8e24 HR Aplenzin 348 MG Extended Release Oral TabletSY1These 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
2315d6e5-144d-4163-9711-f855c759cf8e24 HR bupropion hydrobromide 348 MG Extended Release Oral Tablet [Aplenzin]SBD1These 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