FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
71335-0881
11-digit product format
713350881
Labeler code
71335
Product ID
71335-0881_a148ddb8-adb0-46dc-90ed-7df37af2a4ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075424
Marketing category
ANDA
Marketing start
2001-03-30
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE200 mg/1

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
71335-0881-12024-05-21C16284748780-11030e365-67dc-111a-e063-dadaa90a10e2These 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
71335-0881-22024-05-21C16284748780-11030e365-67dc-111a-e063-dadaa90a10e2These 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
71335-0881-32024-05-21C16284748780-11030e365-67dc-111a-e063-dadaa90a10e2These 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
71335-0881-42024-05-21C16284748780-11030e365-67dc-111a-e063-dadaa90a10e2These 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
71335-0881-52024-05-21C16284748780-11030e365-67dc-111a-e063-dadaa90a10e2These 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
71335-0881-12024-01-30C16284748780-11030e365-67dc-111a-e063-dadaa90a10e2These 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
71335-0881-22024-01-30C16284748780-11030e365-67dc-111a-e063-dadaa90a10e2These 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
71335-0881-32024-01-30C16284748780-11030e365-67dc-111a-e063-dadaa90a10e2These 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
71335-0881-42024-01-30C16284748780-11030e365-67dc-111a-e063-dadaa90a10e2These 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
71335-0881-52024-01-30C16284748780-11030e365-67dc-111a-e063-dadaa90a10e2These 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
71335-0881-1Amiodarone Hydrochloride200 in 1 BOTTLETABLET2005
71335-0881-2Amiodarone Hydrochloride30 in 1 BOTTLETABLET305
71335-0881-3Amiodarone Hydrochloride60 in 1 BOTTLETABLET605
71335-0881-4Amiodarone Hydrochloride90 in 1 BOTTLETABLET905
71335-0881-5Amiodarone Hydrochloride10 in 1 BOTTLETABLET105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0881-2EA - Each71335-0881fe54aca0-8173-45b3-b41c-17f9bea7ec4312020-09-14
71335-0881-4EA - Each71335-0881ca2f5867-db83-44db-a3f4-f5e43cc4b46912020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0881AMIODARONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 5 package rows20240522_f3e631c5-1204-419c-8dbe-fa9b37a77f97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSNf3e631c5-1204-419c-8dbe-fa9b37a77f975
833528amiodarone hydrochloride 200 MG Oral TabletSCDf3e631c5-1204-419c-8dbe-fa9b37a77f975

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0881-171335088101200 TABLET in 1 BOTTLE (71335-0881-1) 200 tablet2021-12-270000-00-00NoNoCurrent
71335-0881-27133508810230 TABLET in 1 BOTTLE (71335-0881-2) 30 tablet2019-01-030000-00-00NoNoCurrent
71335-0881-37133508810360 TABLET in 1 BOTTLE (71335-0881-3) 60 tablet2021-12-270000-00-00NoNoCurrent
71335-0881-47133508810490 TABLET in 1 BOTTLE (71335-0881-4) 90 tablet2018-06-260000-00-00NoNoCurrent
71335-0881-57133508810510 TABLET in 1 BOTTLE (71335-0881-5) 10 tablet2021-12-270000-00-00NoNoCurrent