| NDC Code | 62559-758-04 |
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| Package Description | 118 mL in 1 BOTTLE (62559-758-04) |
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| Product NDC | 62559-758 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Promethazine Hydrochloride And Dextromethorphan Hydrobromide |
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| Non-Proprietary Name | Promethazine Hydrochloride And Dextromethorphan Hydrobromide |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20240905 |
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| Marketing Category Name | NDA AUTHORIZED GENERIC |
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| Application Number | NDA011265 |
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| Manufacturer | ANI Pharmaceuticals, Inc. |
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| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
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| Strength | 15; 6.25 |
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| Strength Unit | mg/5mL; mg/5mL |
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| Pharmacy Classes | Phenothiazine [EPC], Phenothiazines [CS], 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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