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NDC 00245-0144-11 Pacerone 100 mg/1 Details

Pacerone 100 mg/1

Pacerone is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Upsher-Smith Laboratories, LLC. The primary component is AMIODARONE HYDROCHLORIDE.

MedlinePlus Drug Summary

Amiodarone is used to treat and prevent certain types of serious, life-threatening ventricular arrhythmias (a certain type of abnormal heart rhythm when other medications did not help or could not be tolerated. Amiodarone is in a class of medications called antiarrhythmics. It works by relaxing overactive heart muscles.

Related Packages: 00245-0144-11
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Amiodarone

Product Information

NDC	00245-0144
Product ID	0245-0144_c6c66dbb-cc0b-4576-9248-e20255e83cf0
Associated GPIs	35400005000303
GCN Sequence Number	017241
GCN Sequence Number Description	amiodarone HCl TABLET 100 MG ORAL
HIC3	A2A
HIC3 Description	ANTIARRHYTHMICS
GCN	10921
HICL Sequence Number	000083
HICL Sequence Number Description	AMIODARONE HCL
Brand/Generic	Brand
Proprietary Name	Pacerone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Amiodarone Hydrochloride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	AMIODARONE HYDROCHLORIDE
Labeler Name	Upsher-Smith Laboratories, LLC
Pharmaceutical Class	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]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075135
Listing Certified Through	2024-12-31

Package

NDC 00245-0144-11 (00245014411)

Pricing Information	N/A
NDC Package Code	0245-0144-11
Billing NDC	00245014411
Package	100 TABLET in 1 BOTTLE (0245-0144-11)
Marketing Start Date	2011-01-19
NDC Exclude Flag	N