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 11 of 13 · 247 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEA-S Medication Solutionsc536e0ad-2758-4022-8242-f5e9b6aca1e22023-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMedical Purchasing Solutions, LLCd889c00c-e27e-4e27-e053-2995a90ad4e12023-06-01Warnings, Adverse reactionsExact identifier
application number: ANDA075761
ndc (package): 71872-7034-1
ndc (product): 71872-7034
rxcui: 1663224
spl id: fd15b83e-af5c-4e04-e053-6394a90aefd6
spl set id: d889c00c-e27e-4e27-e053-2995a90ad4e1
unii: 976728SY6Z
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMedical Purchasing Solutions, LLC81a15062-ba1e-37c0-e053-2991aa0af9452023-05-16Warnings, Adverse reactionsExact identifier
rxcui: 1663224
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMedical Purchasing Solutions, LLC8969aad3-0219-e67f-e053-2995a90aac5a2023-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1663224
unii: 976728SY6Z
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMedical Purchasing Solutions, LLC66700f8b-3f76-3749-e053-2a91aa0adfdb2023-04-18Warnings, Adverse reactionsExact identifier
rxcui: 1663224
unii: 976728SY6Z
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
amiodarone hydrochlorideAMIODARONE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.b41cbcb5-9c5d-4e45-a4f2-952df5f22c002023-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.a20d0c03-cfda-49d1-88c9-be1bf295bc6c2023-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
AMIODARONE HCIAMIODARONE HCIHF Acquisition Co LLC, DBA HealthFirst993b2557-6774-bb7a-e053-2995a90a05032022-12-10Warnings, Adverse reactionsExact identifier
application number: ANDA075761
ndc (package): 51662-1363-1
ndc (product): 51662-1363
rxcui: 1663224
spl id: ef7bd6e6-d62f-7e93-e053-2a95a90aef83
spl set id: 993b2557-6774-bb7a-e053-2995a90a0503
unii: 976728SY6Z
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
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

Reported adverse events (FAERS/openFDA)#

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