| NDC Code | 65219-120-12 |
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| Package Description | 1 VIAL in 1 PACKAGE (65219-120-12) / 25 mL in 1 VIAL |
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| Product NDC | 65219-120 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Dalbavancin Hydrochloride |
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| Non-Proprietary Name | Dalbavancin Hydrochloride |
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| Dosage Form | INJECTION, POWDER, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20251110 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA217591 |
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| Manufacturer | Fresenius Kabi USA, LLC |
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| Substance Name | DALBAVANCIN HYDROCHLORIDE |
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| Strength | 500 |
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| Strength Unit | mg/25mL |
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| Pharmacy Classes | Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS] |
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