| NDC Code | 0955-1045-90 |
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| Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (0955-1045-90) |
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| Product NDC | 0955-1045 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Irbesartan And Hydrochlorothiazide |
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| Non-Proprietary Name | Irbesartan And Hydrochlorothiazide |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20190930 |
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| Marketing Category Name | NDA AUTHORIZED GENERIC |
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| Application Number | NDA020758 |
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| Manufacturer | Winthrop U.S, a business of sanofi-aventis U.S. LLC |
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| Substance Name | HYDROCHLOROTHIAZIDE; IRBESARTAN |
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| Strength | 12.5; 150 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS] |
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