FDA.reportPublic FDA data

amiodarone HCl 300 MG Oral Tablet

RxCUI
835960
RxNorm name
amiodarone HCl 300 MG Oral Tablet
Display name
amiodarone HCl 300 MG Oral Tablet
Full name
amiodarone HCl 300 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

RxNav Current And Historical NDCs#

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

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
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.7ccd3733-c3af-4a11-8500-0f99194c14722026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835960

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
7ccd3733-c3af-4a11-8500-0f99194c1472amiodarone HCl 300 MG Oral Tablet [PSN] · amiodarone hydrochloride 300 MG Oral Tablet [SCD]219These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 198520260311