
USFDA APPLICATION NUMBER - 22107 / DOSAGE - TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| ALISKIREN HEMIFUMARATE(UNII: C8A0P8G029) (ALISKIREN - UNII:502FWN4Q32) | ALISKIREN | 300mg | 300mg | 150mg | 150mg |
| HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) | HYDROCHLOROTHIAZIDE | 25mg | 12.5mg | 25mg | 12.5mg |
Inactive Ingredients
| Ingredient Name | Novartis Pharmaceuticals Corporation |
|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |
| CROSPOVIDONE(68401960MK) | |
| FERRIC OXIDE RED(1K09F3G675) | |
| HYPROMELLOSES(3NXW29V3WO) | |
| LACTOSE(J2B2A4N98G) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |
| POVIDONE(FZ989GH94E) | |
| SILICON DIOXIDE(ETJ7Z6XBU4) | |
| STARCH, WHEAT(79QS2MG2LP) | |
| TALC(7SEV7J4R1U) | |
| TITANIUM DIOXIDE(15FIX9V2JP) |