| NDC Code | 0641-6254-01 |
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| Package Description | 1 VIAL in 1 CARTON (0641-6254-01) / 20 mL in 1 VIAL |
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| Product NDC | 0641-6254 |
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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 | 20250513 |
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| Marketing Category Name | NDA |
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| Application Number | NDA217812 |
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| Manufacturer | Hikma Pharmaceuticals USA Inc. |
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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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