FDA.reportPublic FDA data

NDC 63323-616-01 - Amiodarone Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63323-616
Requested NDC
63323-616-01
Package NDCs from labels
63323-616-01, 63323-616-03, 63323-616-02, 63323-616-09
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2025-03-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amiodarone Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-03-31HUMAN PRESCRIPTION DRUG LABEL
Amiodarone Hydrochloride - REMEDYREPACK INC.REMEDYREPACK INC.2024-03-06HUMAN PRESCRIPTION DRUG LABEL
Amiodarone Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-06-01HUMAN PRESCRIPTION DRUG LABEL
AMIODARONE HCI - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2022-12-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-616-01Amiodarone Hydrochloride3 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION36
63323-616-02Amiodarone Hydrochloride9 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION96
63323-616-03Amiodarone Hydrochloride25 in 1 TRAYINJECTION, SOLUTION256
63323-616-09Amiodarone Hydrochloride10 in 1 TRAYINJECTION, SOLUTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-616AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 4 package rows20250416_d8d04647-8e25-4127-8ecf-360ce1991c2f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-616-01ML - Milliliter63323-616bf663fdf-9105-4a35-892b-60c1048a333b12024-07-12
63323-616-02ML - Milliliter63323-6166d41f106-aa48-4d74-b69e-fc5a025b2bc712021-11-09
63323-616-03ML - Milliliter63323-6166c9fe469-b588-48f6-894c-3f01eba1912d12012-07-24
63323-616-09ML - Milliliter63323-6168d677ab5-e7f3-486f-92c1-d43c5d514f7b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMIODARONE HYDROCHLORIDEACTIVE INGREDIENT976728SY6ZAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
AMIODARONEACTIVE MOIETYN3RQ532IUTAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1

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 12 of 13 · 249 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: 6OZP39ZG8H
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMylan Institutional LLCf0b3b743-9f62-4b02-ace5-c8d93637ecad2022-03-15Warnings, Adverse reactionsExact identifier
rxcui: 1663244
unii: 976728SY6Z
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAuroMedics Pharma LLC6cd870d7-6381-421a-89bc-bce5c95182192021-12-08Warnings, Adverse reactionsExact identifier
rxcui: 1663244
rxcui: 1663224
unii: 976728SY6Z
Amiodarone hydrochlorideAMIODARONE HYDROCHLORIDEGland Pharma Limited1f00c333-9667-4ebc-8849-009a3779c0c92021-08-26Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMylan Institutional LLCfcc8658c-761a-443f-8c32-1499d86028ec2020-07-15Warnings, Adverse reactionsExact identifier
rxcui: 1663244
rxcui: 1663224
unii: 976728SY6Z

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.