| NDC Code | 58602-867-09 |
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| Package Description | 1 BOTTLE in 1 CARTON (58602-867-09) > 30 TABLET, COATED in 1 BOTTLE |
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| Product NDC | 58602-867 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Ibuprofen And Diphenhydramine Citrate |
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| Non-Proprietary Name | Ibuprofen And Diphenhydramine Citrate |
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| Dosage Form | TABLET, COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20220531 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA216204 |
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| Manufacturer | Aurohealth LLC |
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| Substance Name | DIPHENHYDRAMINE CITRATE; IBUPROFEN |
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| Strength | 38; 200 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC] |
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