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Drug Product Composition: Glibenclamide

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$ API Ref.Price (USD/KG) : 84Xls

USFDA APPLICATION NUMBER - 17532 / DOSAGE - TABLET;ORAL - 1.25MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE(UNII: SX6K58TVWC)
(GLYBURIDE - UNII:SX6K58TVWC)
GLYBURIDE5mg | 2.5mg

Inactive Ingredients

Ingredient Name
Avera McKennan Hospital
AvKARE, Inc.
Bryant Ranch Prepack
Clinical Solutions Wholesale
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Lake Erie Medical DBA Quality Care Products LLC
McKesson Corporation dba SKY Packaging
Mylan Institutional Inc.
NCS HealthCare of KY, Inc dba Vangard Labs
NuCare Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc.
REMEDYREPACK INC.
Sanofi-Aventis U.S. LLC
Unit Dose Services
A-S Medication Solutions
CorePharma, LLC
Legacy Pharmaceutical Packaging, LLC
American Health Packaging
Cardinal Health
Citron Pharma LLC
McKesson Contract Packaging
Medsource Pharmaceuticals
NuCare Pharmaceuticals,Inc.
Major Pharmaceuticals
TruPharma, LLC
Aurobindo Pharma Limited
Preferred Pharmaceuticals, Inc.
ALUMINUM OXIDE(LMI26O6933)             
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)                       
CALCIUM CARBONATE(H0G9379FGK)                           
calcium phosphate, dibasic, anhydrous(L11K75P92J)                         
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)                          
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)         
D&C RED NO. 27(2LRS185U6K)                           
D&C YELLOW NO. 10(35SW5USQ3G)            
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)                     
FD&C BLUE NO. 1(H3R47K3TBD)       
FD&C Red No. 40(WZB9127XOA)                    
FD&C YELLOW NO. 6(H77VEI93A8)                   
FERRIC OXIDE RED(1K09F3G675)                          
FERRIC OXIDE YELLOW(EX438O2MRT)                          
HYDRATED SILICA(Y6O7T4G8P9)                           
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                    
MAGNESIUM PALMITOSTEARATE(R4OXA9G5BV)                         
MAGNESIUM STEARATE(70097M6I30) 
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)             
POVIDONE K29/32(390RMW2PEQ)                           
SILICON DIOXIDE(ETJ7Z6XBU4)              
SODIUM ALGINATE(C269C4G2ZQ)               
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)            
STARCH, CORN(O8232NY3SJ)              
STARCH, PREGELATINIZED CORN(O8232NY3SJ)                           
TALC(7SEV7J4R1U)