FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
62135-576
11-digit product format
621350576
Labeler code
62135
Product ID
62135-576_458bf18b-977a-303b-e063-6294a90a1902
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA077069
Marketing category
ANDA
Marketing start
2017-01-01
Substance
AMIODARONE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui833528, 834348, 835956

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-576-30Amiodarone Hydrochloride30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-576-30EA - Each62135-576bc9ebdd3-49da-4132-b94e-9ca04bd4c37412023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-576AMIODARONE HYDROCHLORIDE TABLET [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241012_5520f11d-968d-4f4f-bf57-d14369c0d746.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835956amiodarone HCl 100 MG Oral TabletPSN5520f11d-968d-4f4f-bf57-d14369c0d7463
833528amiodarone HCl 200 MG Oral TabletPSN5520f11d-968d-4f4f-bf57-d14369c0d7463
834348amiodarone HCl 400 MG Oral TabletPSN5520f11d-968d-4f4f-bf57-d14369c0d7463
835956amiodarone hydrochloride 100 MG Oral TabletSCD5520f11d-968d-4f4f-bf57-d14369c0d7463
833528amiodarone hydrochloride 200 MG Oral TabletSCD5520f11d-968d-4f4f-bf57-d14369c0d7463
834348amiodarone hydrochloride 400 MG Oral TabletSCD5520f11d-968d-4f4f-bf57-d14369c0d7463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-576-306213505763030 TABLET in 1 BOTTLE (62135-576-30) 30 tablet2023-08-17NoNoHistorical