| NDC Code | 63323-671-00 |
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| Package Description | 10 BOTTLE, GLASS in 1 CARTON (63323-671-00) / 100 mL in 1 BOTTLE, GLASS (63323-671-01) |
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| Product NDC | 63323-671 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Dexmedetomidine Hydrochloride |
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| Non-Proprietary Name | Dexmedetomidine Hydrochloride |
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| Dosage Form | INJECTION, SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20190513 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA208129 |
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| Manufacturer | Fresenius Kabi USA, LLC |
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| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
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| Strength | 4 |
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| Strength Unit | ug/mL |
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| Pharmacy Classes | Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE] |
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