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 9 of 13 · 249 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
unii: LKG8494WBH
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
NexteroneAMIODARONE HYDROCHLORIDEBaxter Healthcare Corporatione9108958-b8d7-4fba-87c3-9a32990de5512024-04-16Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.51772745-9ea9-42cd-97e6-7266f41ae3ca2024-04-11Warnings, Adverse reactionsExact identifier
rxcui: 1663224
unii: 976728SY6Z
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst7639dfe4-933c-2916-e053-2a91aa0a3fe72024-02-22Warnings, Adverse reactionsExact identifier
rxcui: 1663224
unii: 976728SY6Z
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
NEXTERONE (AMIODARONE HCI)NEXTERONE (AMIODARONE HCI)HF Acquisition Co LLC, DBA HealthFirst9d4d66f7-fa14-e832-e053-2a95a90a8b622024-02-19Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
PaceroneAMIODARONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC02f4a736-63ed-4ad4-a1f1-b21a71e928bd2024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst8d088060-70b5-e796-e053-2995a90a09692024-01-28Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEA-S Medication Solutionsbfd14110-4bf8-4fbe-a888-7b23fea6ffaa2024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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