| NDC Code | 16571-115-10 |
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| Package Description | 1000 TABLET, FILM COATED in 1 BOTTLE (16571-115-10) |
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| Product NDC | 16571-115 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Hydroxyzine Hydrochloride |
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| Non-Proprietary Name | Hydroxyzine Hydrochloride |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20230822 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA217652 |
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| Manufacturer | Rising Pharma Holdings, Inc. |
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| Substance Name | HYDROXYZINE DIHYDROCHLORIDE |
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| Strength | 50 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |
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