FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
70518-3439
11-digit product format
705183439
Labeler code
70518
Product ID
70518-3439_4f08b135-1138-0c7e-e063-6294a90a51f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078578
Marketing category
ANDA
Marketing start
2022-06-14
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
2027-12-31
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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3439-0Amiodarone Hydrochloride30 in 1 BLISTER PACKTABLET306
70518-3439-1Amiodarone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3439AMIODARONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 2 package rows20250209_337c5695-e3f8-41c6-a088-a492d5c60215.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSN337c5695-e3f8-41c6-a088-a492d5c602156
833528amiodarone hydrochloride 200 MG Oral TabletSCD337c5695-e3f8-41c6-a088-a492d5c602156

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3439-07051834390030 TABLET in 1 BLISTER PACK (70518-3439-0) 30 tablet2022-06-140000-00-00NoNoCurrent
70518-3439-17051834390190 TABLET in 1 BOTTLE, PLASTIC (70518-3439-1) 90 tablet2022-12-180000-00-00NoNoCurrent