USFDA APPLICATION NUMBER - 21842 / DOSAGE - TABLET;ORAL - 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
---|---|---|
metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N) | metformin hydrochloride | 850mg |
pioglitazone hydrochloride(UNII: JQT35NPK6C) (pioglitazone - UNII:X4OV71U42S) | pioglitazone | 15mg |
Inactive Ingredients
Ingredient Name | AvKARE, Inc. | Teva Pharmaceuticals USA | Cardinal Health | Takeda Pharmaceuticals America, Inc. |
---|---|---|---|---|
cellulose, microcrystalline(OP1R32D61U) | ||||
croscarmellose sodium(M28OL1HH48) | ||||
hypromellose 2910 (6 MPA.S)(0WZ8WG20P6) | ||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||
magnesium stearate(70097M6I30) | ||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||
polyethylene glycol 8000(Q662QK8M3B) | ||||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||
POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||
POVIDONES(FZ989GH94E) | ||||
talc(7SEV7J4R1U) | ||||
TITANIUM DIOXIDE(15FIX9V2JP) |
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