| NDC Code | 0713-0823-75 |
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| Package Description | 473 mL in 1 BOTTLE, PLASTIC (0713-0823-75) |
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| Product NDC | 0713-0823 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Promethazine Hydrochloride And Codeine Phosphate |
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| Non-Proprietary Name | Promethazine Hydrochloride And Codeine Phosphate |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20251219 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA200386 |
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| Manufacturer | Cosette Pharmaceuticals, Inc. |
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| Substance Name | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
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| Strength | 10; 6.25 |
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| Strength Unit | mg/5mL; mg/5mL |
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| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS] |
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| DEA Schedule | CV |
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