| NDC Code | 75834-231-10 |
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| Package Description | 10 VIAL, GLASS in 1 CARTON (75834-231-10) / 2 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (75834-231-01) |
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| Product NDC | 75834-231 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Remifentanil Hydrochloride |
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| Non-Proprietary Name | Remifentanil Hydrochloride |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20240904 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA215635 |
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| Manufacturer | Nivagen Pharmaceuticals, Inc. |
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| Substance Name | REMIFENTANIL HYDROCHLORIDE |
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| Strength | 2 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
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| DEA Schedule | CII |
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