Amiodarone HCl is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Cameron Pharmaceuticals, Llc. The primary component is Amiodarone Hydrochloride.
| Product ID | 42494-307_7cda354d-4a32-10c5-e053-2991aa0a3a03 |
| NDC | 42494-307 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Amiodarone HCl |
| Generic Name | Amiodarone Hydrochloride |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-01-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA077069 |
| Labeler Name | Cameron Pharmaceuticals, LLC |
| Substance Name | AMIODARONE HYDROCHLORIDE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-03-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA077069 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-03-01 |
| Marketing End Date | 2018-04-12 |
| Marketing Category | ANDA |
| Application Number | ANDA077069 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-03-01 |
| Ingredient | Strength |
|---|---|
| AMIODARONE HYDROCHLORIDE | 100 mg/1 |
| SPL SET ID: | d779a746-0bdd-49cc-b0d8-5f9a72524b8c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 42494-307 | Amiodarone HCl | Amiodarone Hydrochloride |
| 42494-308 | Amiodarone HCl | Amiodarone HCl |
| 42494-309 | Amiodarone HCl | Amiodarone HCl |
| 51862-154 | Amiodarone HCl | Amiodarone HCl |
| 51862-156 | Amiodarone HCl | Amiodarone HCl |
| 51862-155 | Amiodarone HCl | Amiodarone HCl |
| 52533-101 | Amiodarone HCl | Amiodarone HCl |
| 0143-9875 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 0185-0144 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 0404-9815 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 0615-4545 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 0615-8213 | Amiodarone hydrochloride | Amiodarone hydrochloride |
| 0615-8258 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 0904-6556 | Amiodarone hydrochloride | Amiodarone hydrochloride |
| 0904-6993 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 16714-843 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 16714-844 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 16714-845 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 21695-796 | Amiodarone hydrochloride | Amiodarone hydrochloride |
| 25021-302 | amiodarone hydrochloride | amiodarone hydrochloride |
| 29300-359 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 42291-118 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 42291-139 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 0245-0144 | Pacerone | Amiodarone Hydrochloride |
| 0245-0145 | Pacerone | Amiodarone Hydrochloride |
| 0245-0147 | Pacerone | Amiodarone Hydrochloride |
| 0245-1645 | Pacerone | Amiodarone Hydrochloride |