FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
72888-061
11-digit product format
728880061
Labeler code
72888
Product ID
72888-061_458014a5-2f16-9815-e063-6294a90ad169
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA078578
Marketing category
ANDA
Marketing start
2020-08-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amiodarone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui833528, 834348, 835956

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
72888-061-30Amiodarone Hydrochloride30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-061-30EA - Each72888-0619b266d57-f082-4e97-b846-06b855135a1d12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-061AMIODARONE HYDROCHLORIDE TABLET [ADVAGEN PHARMA LIMITED]4Current NDC, Legacy NDC, 1 package rows20210415_d911b4cf-eec4-43f8-aa64-cc60cfc901b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835956amiodarone HCl 100 MG Oral TabletPSNd911b4cf-eec4-43f8-aa64-cc60cfc901b95
833528amiodarone HCl 200 MG Oral TabletPSNd911b4cf-eec4-43f8-aa64-cc60cfc901b95
834348amiodarone HCl 400 MG Oral TabletPSNd911b4cf-eec4-43f8-aa64-cc60cfc901b95
835956amiodarone hydrochloride 100 MG Oral TabletSCDd911b4cf-eec4-43f8-aa64-cc60cfc901b95
833528amiodarone hydrochloride 200 MG Oral TabletSCDd911b4cf-eec4-43f8-aa64-cc60cfc901b95
834348amiodarone hydrochloride 400 MG Oral TabletSCDd911b4cf-eec4-43f8-aa64-cc60cfc901b95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-061-307288800613030 TABLET in 1 BOTTLE (72888-061-30) 30 tablet2020-08-210000-00-00NoNoCurrent