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Drug Product Composition: Metformin Hydrochloride

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$ API Ref.Price (USD/KG) : 4Xls

USFDA APPLICATION NUMBER - 22024 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
metformin hydrochloride(UNII: 786Z46389E)
(metformin - UNII:9100L32L2N)
metformin hydrochloride1000mg | 1000mg
pioglitazone hydrochloride(UNII: JQT35NPK6C)
(pioglitazone - UNII:X4OV71U42S)
pioglitazone30mg | 15mg

Inactive Ingredients

Ingredient Name
Takeda Pharmaceuticals America, Inc.
Aluminum Oxide(LMI26O6933)
ammonia(5138Q19F1X)
candelilla wax(WL0328HX19)
cellulose acetate(3J2P07GVB6)
FD&C Blue No. 2(L06K8R7DQK)
ferric oxide red(1K09F3G675)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
lactose monohydrate(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
polyethylene glycol 400(B697894SGQ)
polyethylene glycol 8000(Q662QK8M3B)
POVIDONE, UNSPECIFIED(FZ989GH94E)
propylene glycol(6DC9Q167V3)
shellac(46N107B71O)
sodium lauryl sulfate(368GB5141J)
titanium dioxide(15FIX9V2JP)
triacetin(XHX3C3X673)