| NDC Code | 65162-695-86 |
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| Package Description | 118 mL in 1 BOTTLE (65162-695-86) |
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| Product NDC | 65162-695 |
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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 And Codeine |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20130315 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA200894 |
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| Manufacturer | Amneal Pharmaceuticals LLC |
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| Substance Name | PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE |
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| Strength | 6.25; 10 |
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| Strength Unit | mg/5mL; mg/5mL |
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| Pharmacy Classes | Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
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| DEA Schedule | CV |
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