USFDA APPLICATION NUMBER - 19221 / DOSAGE - TABLET;ORAL - 5MG;12.5MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
ENALAPRIL MALEATE(UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM) | ENALAPRIL MALEATE | 10mg |
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) | HYDROCHLOROTHIAZIDE | 25mg |
Inactive Ingredients
Ingredient Name | Cosette Pharmaceuticals, Inc. | Apotex Corp. | Lake Erie Medical DBA Quality Care Products LLC | Mylan Pharmaceuticals Inc. | REMEDYREPACK INC. | Bryant Ranch Prepack | Oceanside Pharmaceuticals |
---|---|---|---|---|---|---|---|
Aluminum Oxide(LMI26O6933) | |||||||
ANHYDROUS LACTOSE(3SY5LH9PMK) | |||||||
FD&C BLUE NO. 2(L06K8R7DQK) | |||||||
FD&C RED NO. 40(WZB9127XOA) | |||||||
FD&C YELLOW NO. 6(H77VEI93A8) | |||||||
FERRIC OXIDE RED(1K09F3G675) | |||||||
FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | |||||||
MAGNESIUM STEARATE(70097M6I30) | |||||||
MALEIC ACID(91XW058U2C) | |||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||
SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||
SODIUM BICARBONATE(8MDF5V39QO) | |||||||
SODIUM LAURYL SULFATE(368GB5141J) | |||||||
STARCH, CORN(O8232NY3SJ) | |||||||
WATER(059QF0KO0R) | |||||||
ZINC STEARATE(H92E6QA4FV) |
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