FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
71335-1985
11-digit product format
713351985
Labeler code
71335
Product ID
71335-1985_b7d415a2-bf21-4d6c-8f01-e1e22a539e42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078578
Marketing category
ANDA
Marketing start
2020-03-09
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
71335-1985-1Amiodarone Hydrochloride200 in 1 BOTTLETABLET200103
71335-1985-2Amiodarone Hydrochloride30 in 1 BOTTLETABLET30103
71335-1985-3Amiodarone Hydrochloride60 in 1 BOTTLETABLET60103
71335-1985-4Amiodarone Hydrochloride90 in 1 BOTTLETABLET90103
71335-1985-5Amiodarone Hydrochloride10 in 1 BOTTLETABLET10103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1985AMIODARONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20231118_f4532f12-3b7a-42ab-9a6c-36fd2a3f192c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSNf4532f12-3b7a-42ab-9a6c-36fd2a3f192c103
833528amiodarone hydrochloride 200 MG Oral TabletSCDf4532f12-3b7a-42ab-9a6c-36fd2a3f192c103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1985-171335198501200 TABLET in 1 BOTTLE (71335-1985-1) 200 tablet2022-10-130000-00-00NoNoCurrent
71335-1985-27133519850230 TABLET in 1 BOTTLE (71335-1985-2) 30 tablet2022-10-130000-00-00NoNoCurrent
71335-1985-37133519850360 TABLET in 1 BOTTLE (71335-1985-3) 60 tablet2022-10-130000-00-00NoNoCurrent
71335-1985-47133519850490 TABLET in 1 BOTTLE (71335-1985-4) 90 tablet2021-10-290000-00-00NoNoCurrent
71335-1985-57133519850510 TABLET in 1 BOTTLE (71335-1985-5) 10 tablet2022-10-130000-00-00NoNoCurrent