| NDC Code | 0378-8158-01 |
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| Package Description | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8158-01) |
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| Product NDC | 0378-8158 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Methylphenidate Hydrochloride |
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| Non-Proprietary Name | Methylphenidate 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 | 20161229 |
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| End Marketing Date | 20221031 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA206726 |
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| Manufacturer | Mylan Pharmaceuticals Inc. |
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| Substance Name | METHYLPHENIDATE HYDROCHLORIDE |
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| Strength | 54 |
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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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