FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
29300-359
11-digit product format
293000359
Labeler code
29300
Product ID
29300-359_ca43a6d6-5537-4881-bf75-b43ade430dd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA213446
Marketing category
ANDA
Marketing start
2020-09-01
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 3A4 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

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
29300-359-05Amiodarone Hydrochloride500 in 1 BOTTLETABLET5005
29300-359-16Amiodarone Hydrochloride60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-359AMIODARONE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]5Current NDC, Legacy NDC, 2 package rows20230224_a20d0c03-cfda-49d1-88c9-be1bf295bc6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSN8377eb89-0d62-48c5-90e7-e96d545a4642104
833528amiodarone hydrochloride 200 MG Oral TabletSCD8377eb89-0d62-48c5-90e7-e96d545a4642104
833528amiodarone HCl 200 MG Oral TabletPSN4c149392-a4f0-4e2d-a13f-2b94810005de7
833528amiodarone hydrochloride 200 MG Oral TabletSCD4c149392-a4f0-4e2d-a13f-2b94810005de7
833528amiodarone HCl 200 MG Oral TabletPSNa20d0c03-cfda-49d1-88c9-be1bf295bc6c5
833528amiodarone HCl 200 MG Oral TabletPSNc536e0ad-2758-4022-8242-f5e9b6aca1e25
833528amiodarone hydrochloride 200 MG Oral TabletSCDa20d0c03-cfda-49d1-88c9-be1bf295bc6c5
833528amiodarone hydrochloride 200 MG Oral TabletSCDc536e0ad-2758-4022-8242-f5e9b6aca1e25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-359-0529300035905500 TABLET in 1 BOTTLE (29300-359-05) 500 tablet2020-09-010000-00-00NoNoCurrent
29300-359-162930003591660 TABLET in 1 BOTTLE (29300-359-16) 60 tablet2020-09-010000-00-00NoNoCurrent