FDA.reportPublic FDA data

amiodarone HCl 100 MG Oral Tablet

RxCUI
835956
RxNorm name
amiodarone HCl 100 MG Oral Tablet
Display name
amiodarone HCl 100 MG Oral Tablet
Full name
amiodarone HCl 100 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:24

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEDr. Reddy's Labratories Inc.95cef33b-c0e6-b17c-7cbb-f5c0668727052026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835956
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.7ccd3733-c3af-4a11-8500-0f99194c14722026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835956
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAvPAK924c9359-ebc4-62a7-e053-2a95a90a43272026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835956
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs28cd0224-3569-4308-bd40-480bc42305032025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835956
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAdvagen Pharma Limitedd911b4cf-eec4-43f8-aa64-cc60cfc901b92025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835956
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEChartwell RX, LLC5520f11d-968d-4f4f-bf57-d14369c0d7462025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835956
PaceroneAMIODARONE HYDROCHLORIDEBryant Ranch Prepackdcadce9c-d0a0-4235-8ff8-dd93c09e03b32025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835956
PaceroneAMIODARONE HYDROCHLORIDEUpsher-Smith Laboratories, LLC4c4ec9b0-13a5-49a8-b57b-b3f64e4316a72025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835956
Amiodarone hydrochlorideAMIODARONE HYDROCHLORIDEZydus Lifesciences Limited3e8db251-e3c5-4fba-be9a-6044a92f0beb2024-11-25Exact identifier
rxcui: 835956
amiodarone hydrochlorideAMIODARONE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.b41cbcb5-9c5d-4e45-a4f2-952df5f22c002023-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835956

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 10 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
dcadce9c-d0a0-4235-8ff8-dd93c09e03b3amiodarone HCl 100 MG Oral Tablet [PSN] · amiodarone hydrochloride 100 MG Oral Tablet [SCD]2101These highlights do not include all the information needed to use PACERONE safely and effectively. See full prescribing information for PACERONE. PACERONE ® (amiodarone hydrochloride) tablets, for oral use Initial U.S. Approval: 198520251105
4c4ec9b0-13a5-49a8-b57b-b3f64e4316a7amiodarone HCl 100 MG Oral Tablet [PSN] · amiodarone hydrochloride 100 MG Oral Tablet [SCD]227These highlights do not include all the information needed to use PACERONE safely and effectively. See full prescribing information for PACERONE. PACERONE ® (amiodarone hydrochloride) tablets, for oral use Initial U.S. Approval: 198520250714
7ccd3733-c3af-4a11-8500-0f99194c1472amiodarone HCl 100 MG Oral Tablet [PSN] · amiodarone hydrochloride 100 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
b41cbcb5-9c5d-4e45-a4f2-952df5f22c00amiodarone HCl 100 MG Oral Tablet [PSN] · amiodarone hydrochloride 100 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: 198520230316
3e8db251-e3c5-4fba-be9a-6044a92f0bebamiodarone HCl 100 MG Oral Tablet [PSN] · amiodarone hydrochloride 100 MG Oral Tablet [SCD]210AMIODARONE HYDROCHLORIDE TABLETS20241125
924c9359-ebc4-62a7-e053-2a95a90a4327amiodarone HCl 100 MG Oral Tablet [PSN] · amiodarone hydrochloride 100 MG Oral Tablet [SCD]25Amiodarone Hydrochloride Tablets Rx Only These highlights do not include all the information needed to use amiodarone hydrochloride tablets safely and effectively. See full prescribing information for amiodarone hydrochloride tablets. Initial U.S. Approval: 198520260108
d911b4cf-eec4-43f8-aa64-cc60cfc901b9amiodarone HCl 100 MG Oral Tablet [PSN] · amiodarone hydrochloride 100 MG Oral Tablet [SCD]25These 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: 198520251209
5520f11d-968d-4f4f-bf57-d14369c0d746amiodarone HCl 100 MG Oral Tablet [PSN] · amiodarone hydrochloride 100 MG Oral Tablet [SCD]23Amiodarone Hydrochloride Tablets, USP These 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: 198520251209
95cef33b-c0e6-b17c-7cbb-f5c066872705amiodarone HCl 100 MG Oral Tablet [PSN] · amiodarone hydrochloride 100 MG Oral Tablet [SCD]22These 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: 198520260423
28cd0224-3569-4308-bd40-480bc4230503amiodarone HCl 100 MG Oral Tablet [PSN] · amiodarone hydrochloride 100 MG Oral Tablet [SCD]21These 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: 198520251222