| NDC Code | 42858-008-12 |
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| Package Description | 1 BOX, UNIT-DOSE in 1 BLISTER PACK (42858-008-12) > 20 CAPSULE, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (42858-008-11) |
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| Product NDC | 42858-008 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Palladone |
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| Non-Proprietary Name | Hydromorphone Hcl |
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| Dosage Form | CAPSULE, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20040924 |
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| Marketing Category Name | NDA |
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| Application Number | NDA021044 |
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| Manufacturer | Rhodes Pharmaceuticals L.P. |
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| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
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| Strength | 12 |
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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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