| NDC Code | 68196-997-56 |
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| Package Description | 1 BLISTER PACK in 1 CARTON (68196-997-56) > 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
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| Product NDC | 68196-997 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Guaifenesin And Dextromethorphan Hydrobromide |
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| Non-Proprietary Name | Guaifenesin And Dextromethorphan Hydrobromide |
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| Dosage Form | TABLET, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20220216 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA214781 |
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| Manufacturer | SAM'S WEST INC |
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| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
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| Strength | 60; 1200 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
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