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NDC 62135-0578-30 Amiodarone Hydrochloride 400 mg/1 Details
Amiodarone Hydrochloride 400 mg/1
Amiodarone Hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Chartwell RX, 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: 62135-0578-30Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Amiodarone
Product Information
| NDC | 62135-0578 |
|---|---|
| Product ID | 62135-578_039ad604-bfb3-01e7-e063-6394a90a7b88 |
| Associated GPIs | |
| 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 | Generic |
| Proprietary Name | Amiodarone Hydrochloride |
| 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 | Chartwell RX, 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 | ANDA077069 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 62135-0578-30 (62135057830)
| NDC Package Code | 62135-578-30 |
|---|---|
| Billing NDC | 62135057830 |
| Package | 30 TABLET in 1 BOTTLE (62135-578-30) |
| Marketing Start Date | 2023-08-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |