FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
50090-3496
11-digit product format
500903496
Labeler code
50090
Product ID
50090-3496_0824ef26-73e2-4624-b338-b65b15edc01b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075424
Marketing category
ANDA
Marketing start
2001-03-30
Marketing end
0000-00-00
Substance
AMIODARONE HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3496-12023-01-30C16284748780-1f386c64a-0525-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
50090-3496-22023-01-30C16284748780-1f386c64a-0525-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3496-1Amiodarone Hydrochloride30 in 1 BOTTLETABLET303
50090-3496-2Amiodarone Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3496AMIODARONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20200121_01935b03-ce4a-4bb9-a7be-954db4d5fec2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSN01935b03-ce4a-4bb9-a7be-954db4d5fec23
833528amiodarone hydrochloride 200 MG Oral TabletSCD01935b03-ce4a-4bb9-a7be-954db4d5fec23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3496-15009034960130 TABLET in 1 BOTTLE (50090-3496-1) 30 tablet2018-08-130000-00-00NoNoCurrent
50090-3496-25009034960290 TABLET in 1 BOTTLE (50090-3496-2) 90 tablet2018-06-250000-00-00NoNoCurrent