| NDC Code | 54868-4191-0 |
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| Package Description | 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-4191-0) |
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| Product NDC | 54868-4191 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Biaxin |
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| Non-Proprietary Name | Clarithromycin |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20001103 |
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| Marketing Category Name | NDA |
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| Application Number | NDA050775 |
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| Manufacturer | Physicians Total Care, Inc. |
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| Substance Name | CLARITHROMYCIN |
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| Strength | 500 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] |
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