
USFDA APPLICATION NUMBER - 21162 / DOSAGE - TABLET;ORAL - 25MG;80MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) | HYDROCHLOROTHIAZIDE | 12.5mg | 25mg |
| TELMISARTAN(UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) | TELMISARTAN | 80mg | 80mg |
Inactive Ingredients
| Ingredient Name | Macleods Pharmaceuticals Limited | Mylan Pharmaceuticals Inc. | Lupin Pharmaceuticals, Inc. | Glenmark Pharmaceuticals Inc., USA | Solco Healthcare LLC | Bryant Ranch Prepack | Zydus Pharmaceuticals USA Inc. | Alembic Pharmaceuticals Inc. | Qualitest Pharmaceuticals | Torrent Pharmaceuticals Limited |
|---|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | ||||||||||
| CROSPOVIDONE (120 .MU.M)(68401960MK) | ||||||||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | ||||||||||
| CROSPOVIDONE(2S7830E561) | ||||||||||
| CROSPOVIDONE(68401960MK) | ||||||||||
| FERRIC OXIDE RED(1K09F3G675) | ||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||||||
| HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82) | ||||||||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | ||||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||||
| MAGNESIUM OXIDE(3A3U0GI71G) | ||||||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||||||
| MANNITOL(3OWL53L36A) | ||||||||||
| MEGLUMINE(6HG8UB2MUY) | ||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||
| POVIDONE K25(K0KQV10C35) | ||||||||||
| POVIDONE K30(U725QWY32X) | ||||||||||
| POVIDONE(FZ989GH94E) | ||||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||||||
| POVIDONES(FZ989GH94E) | ||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||||
| SODIUM HYDROXIDE(55X04QC32I) | ||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||||||||||
| SODIUM STEARYL FUMARATE(7CV7WJK4UI) | ||||||||||
| SORBITOL(506T60A25R) | ||||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||||
| TALC(7SEV7J4R1U) |