| NDC Code | 0116-4024-16 |
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| Package Description | 473 mL in 1 BOTTLE, PLASTIC (0116-4024-16) |
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| Product NDC | 0116-4024 |
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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 | SYRUP |
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| Usage | ORAL |
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| Start Marketing Date | 20250407 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA088864 |
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| Manufacturer | Xttrium Laboratories, 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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