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NDC 70518-2792-01 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 REMEDYREPACK INC.. The primary component is AMIODARONE HYDROCHLORIDE.
Product Information
| NDC | 70518-2792 |
|---|---|
| Product ID | 70518-2792_04b6392e-ffd1-f58e-e063-6394a90a0f2a |
| Associated GPIs | 35400005002030 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| 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 | REMEDYREPACK INC. |
| 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 | ANDA075761 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70518-2792-01 (70518279201)
| NDC Package Code | 70518-2792-1 |
|---|---|
| Billing NDC | 70518279201 |
| Package | 25 VIAL, SINGLE-DOSE in 1 TRAY (70518-2792-1) / 3 mL in 1 VIAL, SINGLE-DOSE (70518-2792-0) |
| Marketing Start Date | 2020-06-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |