USFDA APPLICATION NUMBER - 21532 / DOSAGE - TABLET;ORAL - 25MG;40MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) | HYDROCHLOROTHIAZIDE | 25mg | 12.5mg | 12.5mg |
OLMESARTAN MEDOXOMIL(UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) | OLMESARTAN MEDOXOMIL | 40mg | 40mg | 20mg |
Inactive Ingredients
Ingredient Name | A-S Medication Solutions | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. | REMEDYREPACK INC. | Torrent Pharmaceuticals Limited | Mylan Pharmaceuticals Inc. | Accord Healthcare Inc. | Bryant Ranch Prepack | Cardinal Health | DirectRX | NuCare Pharmaceuticals,Inc. | Solco Healthcare US, LLC | Sun Pharmaceutical Industries, Inc. | Teva Pharmaceuticals USA, Inc. | Alembic Pharmaceuticals Limited |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||||
D&C RED NO. 30(2S42T2808B) | |||||||||||||||
FERRIC OXIDE RED(1K09F3G675) | |||||||||||||||
FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||||||||
FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||||||
HYDROXYPROPYL CELLULOSE (110000 WAMW)(5Y0974F5PW) | |||||||||||||||
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P) | |||||||||||||||
HYDROXYPROPYL CELLULOSE (1200000 WAMW)(U3JF91U133) | |||||||||||||||
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | |||||||||||||||
HYDROXYPROPYL CELLULOSE (200000 MW)(5Y0974F5PW) | |||||||||||||||
HYDROXYPROPYL CELLULOSE (70000 WAMW)(66O7AQV0RT) | |||||||||||||||
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F) | |||||||||||||||
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | |||||||||||||||
HYDROXYPROPYL CELLULOSE (TYPE L)(UKE75GEA7F) | |||||||||||||||
HYDROXYPROPYL CELLULOSE(RFW2ET671P) | |||||||||||||||
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14) | |||||||||||||||
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH) | |||||||||||||||
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82) | |||||||||||||||
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | |||||||||||||||
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | |||||||||||||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||||||||||
HYPROMELLOSES(3NXW29V3WO) | |||||||||||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||||||
LACTOSE(J2B2A4N98G) | |||||||||||||||
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | |||||||||||||||
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)(NZ94SDL6WR) | |||||||||||||||
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 130000 MW)(7773C1ROEU) | |||||||||||||||
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14) | |||||||||||||||
MAGNESIUM STEARATE(70097M6I30) | |||||||||||||||
MICROCRYSTALLINE CELLULOSE 101(7T9FYH5QMK) | |||||||||||||||
MICROCRYSTALLINE CELLULOSE 102(PNR0YF693Y) | |||||||||||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||||||
POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | |||||||||||||||
POLYETHYLENE GLYCOL 4000(4R4HFI6D95) | |||||||||||||||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||||||||||
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | |||||||||||||||
SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||
SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||||||
TALC(7SEV7J4R1U) | |||||||||||||||
titanium dioxide(15FIX9V2JP) |
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