| NDC Code | 53746-522-01 |
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| Package Description | 100 TABLET in 1 BOTTLE (53746-522-01) |
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| Product NDC | 53746-522 |
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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 | TABLET |
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| Usage | ORAL |
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| Start Marketing Date | 20220622 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA091179 |
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| Manufacturer | Amneal Pharmaceuticals of New York LLC |
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| Substance Name | PROMETHAZINE HYDROCHLORIDE |
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| Strength | 50 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Phenothiazine [EPC], Phenothiazines [CS] |
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