FDA.reportPublic FDA data

NDC 0143-9875-01 - 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
0143-9875
Requested NDC
0143-9875-01
Package NDCs from labels
0143-9875-01, 0143-9875-10, 0143-9875-25
Manufacturer
REMEDYREPACK INC.
Effective date
2026-01-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amiodarone Hydrochloride - REMEDYREPACK INC.REMEDYREPACK INC.2026-01-19HUMAN PRESCRIPTION DRUG LABEL
AMIODARONE HYDROCHLORIDE - Henry Schein, Inc.Henry Schein, Inc.2025-10-29HUMAN PRESCRIPTION DRUG LABEL
AMIODARONE - Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.AHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2024-04-11HUMAN PRESCRIPTION DRUG LABEL
AMIODARONE HYDROCHLORIDE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-02-22HUMAN PRESCRIPTION DRUG LABEL
Amiodarone Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-04-18HUMAN PRESCRIPTION DRUG LABEL
AMIODARONE HYDROCHLORIDE - General Injectables and Vaccines, Inc.General Injectables and Vaccines, Inc.2021-03-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9875-01Amiodarone Hydrochloride3 mL in 1 VIALINJECTION, SOLUTION39
0143-9875-10Amiodarone Hydrochloride10 in 1 BOXINJECTION, SOLUTION109
0143-9875-25Amiodarone Hydrochloride25 in 1 BOXINJECTION, SOLUTION259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9875AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 3 package rows20240413_51772745-9ea9-42cd-97e6-7266f41ae3ca.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9875-01ML - Milliliter0143-987535f8ce31-59a3-4017-876c-25a6ecd9ef5912015-11-12
0143-9875-10ML - Milliliter0143-9875260fc820-5fdb-4bec-b572-1b02d1546bc312012-07-24
0143-9875-25ML - Milliliter0143-9875bfa24696-988c-4103-b789-da260d97768912017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMIODARONE HYDROCHLORIDEACTIVE INGREDIENT976728SY6ZAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
AMIODARONEACTIVE MOIETYN3RQ532IUTAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
WATERINACTIVE INGREDIENT059QF0KO0RAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4

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
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
application number: ANDA077234
ndc (package): 0143-9875-10
ndc (package): 0143-9875-25
ndc (package): 0143-9875-01
ndc (product): 0143-9875
ndc11 (package): 00143987501
rxcui: 1663224
spl id: 624376cc-5fa3-410a-95de-ef975e2ea501
spl set id: 51772745-9ea9-42cd-97e6-7266f41ae3ca
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
application number: ANDA077234
ndc (package): 51662-1205-3
ndc (package): 51662-1205-2
ndc (package): 51662-1205-1
ndc (product): 51662-1205
rxcui: 1663224
spl id: 11ff1d81-1f5f-7624-e063-6294a90ad38e
spl set id: 7639dfe4-933c-2916-e053-2a91aa0a3fe7
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
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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