USFDA APPLICATION NUMBER - 22044 / DOSAGE - TABLET;ORAL - 500MG;EQ 50MG BASE
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N) | metformin hydrochloride | 500mg |
SITAGLIPTIN PHOSPHATE(UNII: TS63EW8X6F) (sitagliptin - UNII:QFP0P1DV7Z) | sitagliptin | 50mg |
Inactive Ingredients
Ingredient Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | REMEDYREPACK INC. |
---|---|---|
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||
FERRIC OXIDE RED(1K09F3G675) | ||
FERROSOFERRIC OXIDE(XM0M87F357) | ||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||
POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||
POLYVINYL ALCOHOL(532B59J990) | ||
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | ||
POVIDONE K29/32(390RMW2PEQ) | ||
POVIDONE K30(U725QWY32X) | ||
SODIUM LAURYL SULFATE(368GB5141J) | ||
SODIUM STEARYL FUMARATE(7CV7WJK4UI) | ||
TALC(7SEV7J4R1U) | ||
TITANIUM DIOXIDE(15FIX9V2JP) |
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