| Product NDC: | 67457-176 |
| Proprietary Name: | Sotalol hydrochloride |
| Non Proprietary Name: | Sotalol hydrochloride |
| Active Ingredient(s): | 15 mg/mL & nbsp; Sotalol hydrochloride |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 67457-176 |
| Labeler Name: | Bioniche Pharma USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022306 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090930 |
| Package NDC: | 67457-176-10 |
| Package Description: | 1 VIAL in 1 CARTON (67457-176-10) > 10 mL in 1 VIAL |
| NDC Code | 67457-176-10 |
| Proprietary Name | Sotalol hydrochloride |
| Package Description | 1 VIAL in 1 CARTON (67457-176-10) > 10 mL in 1 VIAL |
| Product NDC | 67457-176 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Sotalol hydrochloride |
| Dosage Form Name | INJECTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20090930 |
| Marketing Category Name | NDA |
| Labeler Name | Bioniche Pharma USA LLC |
| Substance Name | SOTALOL HYDROCHLORIDE |
| Strength Number | 15 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Antiarrhythmic [EPC] |