| NDC Code | 0121-0925-16 |
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| Package Description | 473 mL in 1 BOTTLE (0121-0925-16) |
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| Product NDC | 0121-0925 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Promethazine Vc With Codeine Oral Solution |
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| Non-Proprietary Name | Promethazine And Phenylephrine Hydrochloride And Codeine Phosphate |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20210318 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA040660 |
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| Manufacturer | PAI Holdings, LLC |
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| Substance Name | CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
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| Strength | 10; 5; 6.25 |
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| Strength Unit | mg/5mL; mg/5mL; mg/5mL |
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| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC] |
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| DEA Schedule | CV |
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