FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
65862-732
11-digit product format
658620732
Labeler code
65862
Product ID
65862-732_84ad18a0-1887-4b62-8ac1-94ace3433366
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204742
Marketing category
ANDA
Marketing start
2016-06-03
Substance
AMIODARONE HYDROCHLORIDE
Active strength
200 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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui833528

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
65862-732-01Amiodarone Hydrochloride100 in 1 BOTTLETABLET10010
65862-732-05Amiodarone Hydrochloride500 in 1 BOTTLETABLET50010
65862-732-25Amiodarone Hydrochloride250 in 1 BOTTLETABLET25010
65862-732-30Amiodarone Hydrochloride30 in 1 BOTTLETABLET3010
65862-732-60Amiodarone Hydrochloride60 in 1 BOTTLETABLET6010
65862-732-90Amiodarone Hydrochloride90 in 1 BOTTLETABLET9010
65862-732-99Amiodarone Hydrochloride1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-732-05EA - Each65862-732efddf78d-9881-436b-97ec-c6733b7552f412016-07-19
65862-732-60EA - Each65862-73279a1dfdf-4d01-4775-bac1-23dd7dc3a55012016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-732AMIODARONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 7 package rows20240615_7ae393d1-7469-432a-9f21-f5ebab1207d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSN51a88e8e-da02-4b97-9e7e-442fbffd908d11
833528amiodarone hydrochloride 200 MG Oral TabletSCD51a88e8e-da02-4b97-9e7e-442fbffd908d11
833528amiodarone HCl 200 MG Oral TabletPSN7ae393d1-7469-432a-9f21-f5ebab1207d110
833528amiodarone HCl 200 MG Oral TabletPSNbfd14110-4bf8-4fbe-a888-7b23fea6ffaa10
833528amiodarone hydrochloride 200 MG Oral TabletSCD7ae393d1-7469-432a-9f21-f5ebab1207d110
833528amiodarone hydrochloride 200 MG Oral TabletSCDbfd14110-4bf8-4fbe-a888-7b23fea6ffaa10
833528amiodarone HCl 200 MG Oral TabletPSNd912a75a-ddac-4e7b-b5c4-321d4252ec057
833528amiodarone hydrochloride 200 MG Oral TabletSCDd912a75a-ddac-4e7b-b5c4-321d4252ec057
833528amiodarone HCl 200 MG Oral TabletPSNd42293e9-07fa-41b4-a08b-2e388f5b1e134
833528amiodarone hydrochloride 200 MG Oral TabletSCDd42293e9-07fa-41b4-a08b-2e388f5b1e134

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-732-0165862073201100 TABLET in 1 BOTTLE (65862-732-01) 100 tablet2016-06-030000-00-00NoNoCurrent
65862-732-0565862073205500 TABLET in 1 BOTTLE (65862-732-05) 500 tablet2016-06-030000-00-00NoNoCurrent
65862-732-2565862073225250 TABLET in 1 BOTTLE (65862-732-25) 250 tablet2016-06-030000-00-00NoNoCurrent
65862-732-306586207323030 TABLET in 1 BOTTLE (65862-732-30) 30 tablet2016-06-030000-00-00NoNoCurrent
65862-732-606586207326060 TABLET in 1 BOTTLE (65862-732-60) 60 tablet2016-06-030000-00-00NoNoCurrent
65862-732-906586207329090 TABLET in 1 BOTTLE (65862-732-90) 90 tablet2016-06-030000-00-00NoNoCurrent
65862-732-99658620732991000 TABLET in 1 BOTTLE (65862-732-99) 1000 tablet2016-06-030000-00-00NoNoCurrent