| NDC Code | 63323-853-25 |
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| Package Description | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-853-25) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-853-03) |
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| Product NDC | 63323-853 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Hydromorphone Hydrochloride |
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| Non-Proprietary Name | Hydromorphone Hydrochloride |
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| Dosage Form | INJECTION, SOLUTION |
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| Usage | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
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| Start Marketing Date | 20171215 |
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| Marketing Category Name | NDA |
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| Application Number | NDA019034 |
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| Manufacturer | Fresenius Kabi USA, LLC |
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| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
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| Strength | 2 |
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| Strength Unit | mg/mL |
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| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
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| DEA Schedule | CII |
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