FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
50090-5766
11-digit product format
500905766
Labeler code
50090
Product ID
50090-5766_144da1fc-bf68-44fc-a6ad-9f1d00d6838f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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 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
50090-5766-12023-02-07C16284748780-1f386c64a-1e58-0266-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 Initial U.S. Approval: 1985
50090-5766-22023-02-07C16284748780-1f386c64a-1e58-0266-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 Initial U.S. Approval: 1985
50090-5766-12023-01-30C16284748780-1f386c64a-1e58-0266-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 Initial U.S. Approval: 1985
50090-5766-22023-01-30C16284748780-1f386c64a-1e58-0266-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 Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5766-1Amiodarone Hydrochloride30 in 1 BOTTLETABLET305
50090-5766-2Amiodarone Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5766-1EA - Each50090-5766466f03d0-164a-45ff-85b8-78494a9de7ae12023-02-06
50090-5766-2EA - Each50090-5766cfab4e62-4dc9-4c2d-8e09-33eae83f88da12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5766AMIODARONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230823_c536e0ad-2758-4022-8242-f5e9b6aca1e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSNc536e0ad-2758-4022-8242-f5e9b6aca1e25
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
50090-5766-15009057660130 TABLET in 1 BOTTLE (50090-5766-1) 30 tablet2021-10-040000-00-00NoNoCurrent
50090-5766-25009057660290 TABLET in 1 BOTTLE (50090-5766-2) 90 tablet2021-10-070000-00-00NoNoCurrent