| NDC Code | 0591-3631-01 |
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| Package Description | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3631-01) |
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| Product NDC | 0591-3631 |
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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 | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20161010 |
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| End Marketing Date | 20190831 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA202144 |
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| Manufacturer | Actavis Pharma, Inc. |
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| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
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| Strength | 32 |
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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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