Amiodarone hydrochloride

Product NDC
53808-1066
11-digit product format
538081066
Labeler code
53808
Product ID
53808-1066_4c892a60-2a09-4a71-aff4-40d881fd7de4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA079029
Marketing category
ANDA
Marketing start
2014-11-01
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
2019-12-31
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
53808-1066-12020-01-31C16284748780-19d75b9d0-be3c-f424-e053-dadaa90a57ceAmiodarone Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1066-1Amiodarone hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1066AMIODARONE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20141219_d40060cd-e462-4952-866d-4e50fa13dce2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSNd40060cd-e462-4952-866d-4e50fa13dce21
833528amiodarone hydrochloride 200 MG Oral TabletSCDd40060cd-e462-4952-866d-4e50fa13dce21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-1066-15380810660130 in 1 BLISTER PACKHistorical