| NDC Code | 0121-1854-16 |
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| Package Description | 473 mL in 1 BOTTLE (0121-1854-16) |
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| Product NDC | 0121-1854 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Promethazine Hydrochloride |
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| Non-Proprietary Name | Promethazine Hydrochloride |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20250807 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA040643 |
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| Manufacturer | PAI Holdings, LLC dba PAI Pharma |
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| Substance Name | PROMETHAZINE HYDROCHLORIDE |
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| Strength | 6.25 |
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| Strength Unit | mg/5mL |
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| Pharmacy Classes | Phenothiazine [EPC], Phenothiazines [CS] |
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