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Drug Product Composition: Prestwick3_000131

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$ API Ref.Price (USD/KG) : 286Xls

USFDA APPLICATION NUMBER - 20329 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glipizide(UNII: X7WDT95N5C)
(glipizide - UNII:X7WDT95N5C)
glipizide10mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Actavis Pharma, Inc.
Aurobindo Pharma Limited
Avera McKennan Hospital
Bryant Ranch Prepack
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Lake Erie Medical DBA Quality Care Products LLC
NCS HealthCare of KY, Inc dba Vangard Labs
NuCare Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
Par Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
REMEDYREPACK INC.
NuCare Pharmaceuticals Inc,
Par Pharmaceutical, Inc.
St. Mary's Medical Park Pharmacy
Cardinal Health
Mylan Pharmaceuticals Inc.
REMEDYREPACK INC.
St Marys Medical Park Pharmacy
ACETYLTRIBUTYL CITRATE(0ZBX0N59RZ)       
AMMONIA(5138Q19F1X)         
ANHYDROUS LACTOSE(3SY5LH9PMK)             
BUTYL ALCOHOL(8PJ61P6TS3)            
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)             
CELLULOSE ACETATE(3J2P07GVB6)         
CETEARETH-8(4W0XA5SY57)             
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)                   
FERROSOFERRIC OXIDE(XM0M87F357)     
GLYCERYL MONOSTEARATE(230OU9XXE4)             
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)(S38J6RZN16)                  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(S38J6RZN16)           
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(ZYD53NBL45)                
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                   
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                   
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)                
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)            
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)                
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)                  
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                  
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)               
HYPROMELLOSES(3NXW29V3WO)             
ISOPROPYL ALCOHOL(ND2M416302)            
LACTOSE MONOHYDRATE(EWQ57Q8I5X)       
MAGNESIUM STEARATE(70097M6I30)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)       
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)             
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                  
POLYETHYLENE GLYCOL 400(B697894SGQ)              
polyethylene glycol(3WJQ0SDW1A)                  
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)           
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)        
POLYETHYLENE OXIDE 200000(11628IH70O)                  
POLYETHYLENE OXIDE 7000000(G3MS6M810Y)                  
POLYSORBATE 80(6OZP39ZG8H)             
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                   
PROPYLENE GLYCOL(6DC9Q167V3)     
SHELLAC(46N107B71O)         
SILICON DIOXIDE(ETJ7Z6XBU4)            
SODIUM CHLORIDE(451W47IQ8X)         
SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B)             
SODIUM STEARYL FUMARATE(7CV7WJK4UI)                   
TALC(7SEV7J4R1U)                   
TITANIUM DIOXIDE(15FIX9V2JP)           
TRIACETIN(XHX3C3X673)