FDA.reportPublic FDA data

FDA labels

Search the openFDA drug-label export by label identifier, NDC, application, RxCUI, UNII, product name, or manufacturer.

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report.

Label matches#

FDA label search results page 2 of 2 · 49 matching rows.

Label, Generic name, Manufacturer table
LabelGeneric nameManufacturerSPL set IDEffective dateSafety fieldsMatch
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.a20d0c03-cfda-49d1-88c9-be1bf295bc6c2023-02-23Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMylan Institutional LLCf0b3b743-9f62-4b02-ace5-c8d93637ecad2022-03-15Warnings, Adverse reactionsName/manufacturer search
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAuroMedics Pharma LLC6cd870d7-6381-421a-89bc-bce5c95182192021-12-08Warnings, Adverse reactionsName/manufacturer search
Amiodarone hydrochlorideAMIODARONE HYDROCHLORIDEGland Pharma Limited1f00c333-9667-4ebc-8849-009a3779c0c92021-08-26Warnings, Adverse reactionsName/manufacturer search
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMylan Institutional LLCfcc8658c-761a-443f-8c32-1499d86028ec2020-07-15Warnings, Adverse reactionsName/manufacturer search
PaceroneAMIODARONE HYDROCHLORIDEBryant Ranch Prepackdcadce9c-d0a0-4235-8ff8-dd93c09e03b32025-11-05Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PaceroneAMIODARONE HYDROCHLORIDEUpsher-Smith Laboratories, LLC4c4ec9b0-13a5-49a8-b57b-b3f64e4316a72025-07-14Boxed warning, Warnings, Adverse reactionsName/manufacturer search
NexteroneAMIODARONE HYDROCHLORIDEBaxter Healthcare Corporatione9108958-b8d7-4fba-87c3-9a32990de5512024-04-16Warnings, Adverse reactionsName/manufacturer search
PaceroneAMIODARONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC02f4a736-63ed-4ad4-a1f1-b21a71e928bd2024-02-02Boxed warning, Warnings, Adverse reactionsName/manufacturer search