| NDC Code | 50458-585-01 |
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| Package Description | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-585-01) |
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| Product NDC | 50458-585 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Concerta |
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| Non-Proprietary Name | Methylphenidate Hydrochloride |
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| Dosage Form | TABLET, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20000801 |
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| Marketing Category Name | NDA |
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| Application Number | NDA021121 |
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| Manufacturer | Janssen Pharmaceuticals, Inc. |
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| Substance Name | METHYLPHENIDATE HYDROCHLORIDE |
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| Strength | 18 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
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| DEA Schedule | CII |
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