FDA.reportPublic FDA data

NDC 51672-4056-01 - 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
51672-4056
Requested NDC
51672-4056-01
Package NDCs from labels
51672-4056-6, 51672-4056-1, 51672-4056-3, 51672-4056-0, 51672-4056-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.
Effective date
2026-03-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amiodarone HydrochlorideSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2026-03-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4056-0Amiodarone Hydrochloride10 in 1 BLISTER PACKTABLET1019
51672-4056-0Amiodarone Hydrochloride10 in 1 CARTONTABLET1019
51672-4056-1Amiodarone Hydrochloride100 in 1 BOTTLETABLET10019
51672-4056-3Amiodarone Hydrochloride1000 in 1 BOTTLETABLET100019
51672-4056-6Amiodarone Hydrochloride30 in 1 BOTTLETABLET3019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4056AMIODARONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]18Current NDC, Legacy NDC, 5 package rows20250406_7ccd3733-c3af-4a11-8500-0f99194c1472.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amiodarone HydrochlorideACTIVE INGREDIENT976728SY6ZAMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]9
AmiodaroneACTIVE MOIETYN3RQ532IUTAMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]9
aluminum oxideINACTIVE INGREDIENTLMI26O6933AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]9
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKAMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]9
D&C yellow No. 10INACTIVE INGREDIENT35SW5USQ3GAMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]9
FD&C yellow No. 6INACTIVE INGREDIENTH77VEI93A8AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]9
magnesium stearateINACTIVE INGREDIENT70097M6I30AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]9
povidonesINACTIVE INGREDIENTFZ989GH94EAMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]9
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]9
starch, cornINACTIVE INGREDIENTO8232NY3SJAMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]9

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 38 of 38 · 742 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ThyrotoxCHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.e229a260-13f3-4136-b325-9a8954f8a3272016-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
TeethingARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEABioActive Nutritional, Inc.f39c9feb-f567-43a2-a026-2a581aeeed9d2016-07-27WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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