FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
50090-3015
11-digit product format
500903015
Labeler code
50090
Product ID
50090-3015_40234dbd-66e0-4246-94ce-08d7457069f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204742
Marketing category
ANDA
Marketing start
2016-06-03
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

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
50090-3015-12024-01-29C16284748780-1f386c64a-459c-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
50090-3015-22024-01-29C16284748780-1f386c64a-459c-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
50090-3015-12023-01-30C16284748780-1f386c64a-459c-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
50090-3015-22023-01-30C16284748780-1f386c64a-459c-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
50090-3015-1Amiodarone Hydrochloride30 in 1 BOTTLETABLET3010
50090-3015-2Amiodarone Hydrochloride90 in 1 BOTTLETABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3015-1EA - Each50090-3015adc50207-999d-4186-81ca-f2f4f2c3f06812019-05-02
50090-3015-2EA - Each50090-3015d50dbe61-3903-4080-8452-a7a99d9914a812021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3015AMIODARONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20240130_bfd14110-4bf8-4fbe-a888-7b23fea6ffaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSNbfd14110-4bf8-4fbe-a888-7b23fea6ffaa10
833528amiodarone hydrochloride 200 MG Oral TabletSCDbfd14110-4bf8-4fbe-a888-7b23fea6ffaa10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3015-15009030150130 TABLET in 1 BOTTLE (50090-3015-1) 30 tablet2017-05-120000-00-00NoNoCurrent
50090-3015-25009030150290 TABLET in 1 BOTTLE (50090-3015-2) 90 tablet2018-06-120000-00-00NoNoCurrent