| NDC Code | 64239-112-03 |
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| Package Description | 2 CARTON in 1 CARTON (64239-112-03) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
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| Product NDC | 64239-112 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Esomeprazole |
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| Non-Proprietary Name | Esomeprazole |
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| Dosage Form | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20240412 |
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| Marketing Category Name | NDA |
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| Application Number | NDA214278 |
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| Manufacturer | Dexcel Pharma Technologies Ltd |
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| Substance Name | ESOMEPRAZOLE |
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| Strength | 20 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
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