| NDC Code | 69189-0116-1 |
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| Package Description | 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 DOSE PACK (69189-0116-1) |
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| Product NDC | 69189-0116 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Zolpidem Tartrate |
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| Proprietary Name Suffix | Extended-release |
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| Non-Proprietary Name | Zolpidem Tartrate |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20150629 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA078148 |
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| Manufacturer | Avera McKennan Hospital |
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| Substance Name | ZOLPIDEM TARTRATE |
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| Strength | 12.5 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] |
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| DEA Schedule | CIV |
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