FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
70518-3246
11-digit product format
705183246
Labeler code
70518
Product ID
70518-3246_50120dea-7fa0-f105-e063-6394a90a6989
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213446
Marketing category
ANDA
Marketing start
2021-10-15
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3246-02023-03-23C16284748780-1f386c64a-4098-0266-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
70518-3246-02023-01-30C16284748780-1f386c64a-4098-0266-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
70518-3246-0Amiodarone Hydrochloride30 in 1 BLISTER PACKTABLET307
70518-3246-1Amiodarone Hydrochloride50 in 1 BOXTABLET507
70518-3246-2Amiodarone Hydrochloride1 in 1 POUCHTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3246AMIODARONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 3 package rows20240830_4c149392-a4f0-4e2d-a13f-2b94810005de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSN4c149392-a4f0-4e2d-a13f-2b94810005de7
833528amiodarone hydrochloride 200 MG Oral TabletSCD4c149392-a4f0-4e2d-a13f-2b94810005de7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3246-07051832460030 TABLET in 1 BLISTER PACK (70518-3246-0) 30 tablet2021-10-150000-00-00NoNoCurrent
70518-3246-17051832460150 POUCH in 1 BOX (70518-3246-1) / 1 TABLET in 1 POUCH (70518-3246-2) 50 pouch2026-04-22NoNoCurrent
70518-3246-2705183246021 in 1 POUCHHistorical