FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
51672-4057
11-digit product format
516724057
Labeler code
51672
Product ID
51672-4057_4cc4c3cb-aced-a125-e063-6394a90aee93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076362
Marketing category
ANDA
Marketing start
2002-11-29
Substance
AMIODARONE HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amiodarone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui833528, 834348, 835956, 835960

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
555d5389-223f-1ce8-3064-82307acfdb0dProduct name420250325
b88d5283-0ee6-f0b3-21f1-5522444ef3dfProduct name320210204
555d5389-223f-1ce8-3064-82307acfdb0dProduct name320171213
1f5577c0-bdff-03f7-f803-d1d3f05329c2Product name120140508
a0ee8fe5-e56a-6ca2-24dc-111ec6d188e4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4057-0Amiodarone Hydrochloride10 in 1 CARTONTABLET1019
51672-4057-0Amiodarone Hydrochloride10 in 1 BLISTER PACKTABLET1019
51672-4057-6Amiodarone Hydrochloride30 in 1 BOTTLETABLET3019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4057-0EA - Each51672-4057bf284503-aa21-42d8-a445-b612ea965f1612012-07-24
51672-4057-6EA - Each51672-4057e8dc37dc-40eb-42b4-8cac-d08660fddc9712012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4057AMIODARONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]18Current NDC, Legacy NDC, 3 package rows20250406_7ccd3733-c3af-4a11-8500-0f99194c1472.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835956amiodarone HCl 100 MG Oral TabletPSN7ccd3733-c3af-4a11-8500-0f99194c147219
833528amiodarone HCl 200 MG Oral TabletPSN7ccd3733-c3af-4a11-8500-0f99194c147219
835960amiodarone HCl 300 MG Oral TabletPSN7ccd3733-c3af-4a11-8500-0f99194c147219
834348amiodarone HCl 400 MG Oral TabletPSN7ccd3733-c3af-4a11-8500-0f99194c147219
835956amiodarone hydrochloride 100 MG Oral TabletSCD7ccd3733-c3af-4a11-8500-0f99194c147219
833528amiodarone hydrochloride 200 MG Oral TabletSCD7ccd3733-c3af-4a11-8500-0f99194c147219
835960amiodarone hydrochloride 300 MG Oral TabletSCD7ccd3733-c3af-4a11-8500-0f99194c147219
834348amiodarone hydrochloride 400 MG Oral TabletSCD7ccd3733-c3af-4a11-8500-0f99194c147219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4057-05167240570010 BLISTER PACK in 1 CARTON (51672-4057-0) / 10 TABLET in 1 BLISTER PACK10 blister pack2002-11-290000-00-00NoNoCurrent
51672-4057-65167240570630 TABLET in 1 BOTTLE (51672-4057-6) 30 tablet2002-11-290000-00-00NoNoCurrent