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NDC 63323-0616-09 Amiodarone Hydrochloride 50 mg/mL Details
Amiodarone Hydrochloride 50 mg/mL
Amiodarone Hydrochloride is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is AMIODARONE HYDROCHLORIDE.
Product Information
| NDC | 63323-0616 |
|---|---|
| Product ID | 63323-616_faf36761-7b49-425a-b941-5aba638df545 |
| Associated GPIs | 35400005002030 35400005002040 |
| GCN Sequence Number | 050676 |
| GCN Sequence Number Description | amiodarone HCl VIAL 50 MG/ML INTRAVEN |
| HIC3 | A2A |
| HIC3 Description | ANTIARRHYTHMICS |
| GCN | 17795 |
| 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 | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | AMIODARONE HYDROCHLORIDE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075761 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0616-09 (63323061609)
| NDC Package Code | 63323-616-09 |
|---|---|
| Billing NDC | 63323061609 |
| Package | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-09) / 9 mL in 1 VIAL, SINGLE-DOSE (63323-616-02) |
| Marketing Start Date | 2003-01-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |