FDA.reportPublic FDA data

Amiodarone hydrochloride

Product NDC
65841-631
11-digit product format
658410631
Labeler code
65841
Product ID
65841-631_aabb5533-5d41-49a3-b8b6-14627af57311
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA079029
Marketing category
ANDA
Marketing start
2009-08-10
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
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 HYDROCHLORIDE200 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
65841-631-05Amiodarone hydrochloride500 in 1 BOTTLETABLET50010
65841-631-06Amiodarone hydrochloride30 in 1 BOTTLETABLET3010
65841-631-10Amiodarone hydrochloride1000 in 1 BOTTLETABLET100010
65841-631-14Amiodarone hydrochloride60 in 1 BOTTLETABLET6010
65841-631-77Amiodarone hydrochloride10 in 1 BLISTER PACKTABLET1010
65841-631-77Amiodarone hydrochloride10 in 1 CARTONTABLET1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-631AMIODARONE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]10Current NDC, Legacy NDC, 6 package rows20241127_3e8db251-e3c5-4fba-be9a-6044a92f0beb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835956amiodarone HCl 100 MG Oral TabletPSN3e8db251-e3c5-4fba-be9a-6044a92f0beb10
833528amiodarone HCl 200 MG Oral TabletPSN3e8db251-e3c5-4fba-be9a-6044a92f0beb10
834348amiodarone HCl 400 MG Oral TabletPSN3e8db251-e3c5-4fba-be9a-6044a92f0beb10
835956amiodarone hydrochloride 100 MG Oral TabletSCD3e8db251-e3c5-4fba-be9a-6044a92f0beb10
833528amiodarone hydrochloride 200 MG Oral TabletSCD3e8db251-e3c5-4fba-be9a-6044a92f0beb10
834348amiodarone hydrochloride 400 MG Oral TabletSCD3e8db251-e3c5-4fba-be9a-6044a92f0beb10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-631-0565841063105500 TABLET in 1 BOTTLE (65841-631-05) 500 tablet2009-08-100000-00-00NoNoCurrent
65841-631-066584106310630 TABLET in 1 BOTTLE (65841-631-06) 30 tablet2009-08-100000-00-00NoNoCurrent
65841-631-10658410631101000 TABLET in 1 BOTTLE (65841-631-10) 1000 tablet2009-08-100000-00-00NoNoCurrent
65841-631-146584106311460 TABLET in 1 BOTTLE (65841-631-14) 60 tablet2009-08-100000-00-00NoNoCurrent
65841-631-306584106313010 BLISTER PACK in 1 CARTON (65841-631-30) > 10 TABLET in 1 BLISTER PACK10 blister pack2009-08-100000-00-00NoNoCurrent
65841-631-776584106317710 BLISTER PACK in 1 CARTON (65841-631-77) / 10 TABLET in 1 BLISTER PACK10 blister pack2009-08-10NoNoCurrent