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NDC 00245-1645-30 Pacerone 400 mg/1 Details
Pacerone 400 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: 00245-1645-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Amiodarone
Product Information
NDC | 00245-1645 |
---|---|
Product ID | 0245-1645_c6c66dbb-cc0b-4576-9248-e20255e83cf0 |
Associated GPIs | 35400005000320 |
GCN Sequence Number | 047421 |
GCN Sequence Number Description | amiodarone HCl TABLET 400 MG ORAL |
HIC3 | A2A |
HIC3 Description | ANTIARRHYTHMICS |
GCN | 12465 |
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 | 400 |
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 00245-1645-30 (00245164530)
NDC Package Code | 0245-1645-30 |
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Billing NDC | 00245164530 |
Package | 30 TABLET in 1 BOTTLE (0245-1645-30) |
Marketing Start Date | 2020-10-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |