| NDC Code | 70069-759-04 |
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| Package Description | 4 VIAL in 1 CARTON (70069-759-04) / 10 mL in 1 VIAL |
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| Product NDC | 70069-759 |
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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 | 20240926 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA218112 |
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| Manufacturer | Somerset Therapeutics, LLC |
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| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
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| Strength | 100 |
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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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