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USFDA APPLICATION NUMBER - 20758 / DOSAGE - TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| hydrochlorothiazide(UNII: 0J48LPH2TH) (hydrochlorothiazide - UNII:0J48LPH2TH) | hydrochlorothiazide | 12.5mg | 12.5mg |
| irbesartan(UNII: J0E2756Z7N) (irbesartan - UNII:J0E2756Z7N) | irbesartan | 300mg | 150mg |
Inactive Ingredients
| Ingredient Name | Cardinal Health |
|---|---|
| carnauba wax(R12CBM0EIZ) | |
| croscarmellose sodium(M28OL1HH48) | |
| ferric oxide red(1K09F3G675) | |
| ferric oxide yellow(EX438O2MRT) | |
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |
| lactose monohydrate(EWQ57Q8I5X) | |
| magnesium stearate(70097M6I30) | |
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |
| silicon dioxide(ETJ7Z6XBU4) | |
| starch, corn(O8232NY3SJ) | |
| titanium dioxide(15FIX9V2JP) |
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