FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
71335-1942
11-digit product format
713351942
Labeler code
71335
Product ID
71335-1942_5b27ec4d-eebc-445d-a4ab-fced073afaa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1942-1Amiodarone Hydrochloride200 in 1 BOTTLETABLET200104
71335-1942-2Amiodarone Hydrochloride30 in 1 BOTTLETABLET30104
71335-1942-3Amiodarone Hydrochloride60 in 1 BOTTLETABLET60104
71335-1942-4Amiodarone Hydrochloride90 in 1 BOTTLETABLET90104
71335-1942-5Amiodarone Hydrochloride10 in 1 BOTTLETABLET10104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1942-2EA - Each71335-1942a4a454df-81cd-4e5f-b5d0-6486bb599aa912025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1942AMIODARONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20241004_8377eb89-0d62-48c5-90e7-e96d545a4642.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSN8377eb89-0d62-48c5-90e7-e96d545a4642104
833528amiodarone hydrochloride 200 MG Oral TabletSCD8377eb89-0d62-48c5-90e7-e96d545a4642104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1942-171335194201200 TABLET in 1 BOTTLE (71335-1942-1) 200 tablet2021-09-030000-00-00NoNoCurrent
71335-1942-27133519420230 TABLET in 1 BOTTLE (71335-1942-2) 30 tablet2021-09-030000-00-00NoNoCurrent
71335-1942-37133519420360 TABLET in 1 BOTTLE (71335-1942-3) 60 tablet2021-09-030000-00-00NoNoCurrent
71335-1942-47133519420490 TABLET in 1 BOTTLE (71335-1942-4) 90 tablet2021-09-030000-00-00NoNoCurrent
71335-1942-57133519420510 TABLET in 1 BOTTLE (71335-1942-5) 10 tablet2021-09-030000-00-00NoNoCurrent