FDA.reportPublic FDA data

Pacerone

Product NDC
72162-2148
11-digit product format
721622148
Labeler code
72162
Product ID
72162-2148_b3dbe38d-29a3-41a9-a51c-0cc3bf8eb9e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075135
Marketing category
ANDA
Marketing start
2010-11-15
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
Pacerone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui835956, 835958

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
72162-2148-3Pacerone30 in 1 BOTTLETABLET30101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2148-3EA - Each72162-214894b51739-5bdf-4948-b19f-2de5c5a8f8a412024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2148PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20231208_dcadce9c-d0a0-4235-8ff8-dd93c09e03b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835956amiodarone HCl 100 MG Oral TabletPSNdcadce9c-d0a0-4235-8ff8-dd93c09e03b3101
835958Pacerone 100 MG Oral TabletPSNdcadce9c-d0a0-4235-8ff8-dd93c09e03b3101
835958amiodarone hydrochloride 100 MG Oral Tablet [Pacerone]SBDdcadce9c-d0a0-4235-8ff8-dd93c09e03b3101
835956amiodarone hydrochloride 100 MG Oral TabletSCDdcadce9c-d0a0-4235-8ff8-dd93c09e03b3101
835958Pacerone 100 MG Oral TabletSYdcadce9c-d0a0-4235-8ff8-dd93c09e03b3101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2148-37216221480330 TABLET in 1 BOTTLE (72162-2148-3) 30 tablet2023-12-07NoNoCurrent