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Drug Product Composition: Metformin Hydrochloride

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

USFDA APPLICATION NUMBER - 201281 / DOSAGE - TABLET;ORAL - 2.5MG;500MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LINAGLIPTIN(UNII: 3X29ZEJ4R2)
(LINAGLIPTIN - UNII:3X29ZEJ4R2)
LINAGLIPTIN2.5mg
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N)
METFORMIN HYDROCHLORIDE1000mg

Inactive Ingredients

Ingredient Name
Actavis Pharma, Inc.
Lake Erie Medical DBA Quality Care Products LLC
Medsource Pharmaceuticals
PD-Rx Pharmaceuticals, Inc.
Unit Dose Services
Actavis Pharma Inc.
Impax Generics
Bryant Ranch Prepack
Zydus Pharmaceuticals (USA) Inc.
A-S Medication Solutions
American Health Packaging
Clinical Solutions Wholesale
KAISER FOUNDATION HOSPITALS
NuCare Pharmaceuticals,Inc.
REMEDYREPACK INC.
St Marys Medical Park Pharmacy
Teva Pharmaceuticals USA, Inc.
Mylan Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
REMEDYREPACK INC.
ALUMINUM OXIDE(LMI26O6933)                 
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)                  
CALCIUM CARBONATE(H0G9379FGK)                   
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)           
COPOVIDONE K25-31(D9C330MD8B)                 
COPOVIDONE(D9C330MD8B)                    
CROSCARMELLOSE SODIUM(M28OL1HH48)    
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                  
CROSPOVIDONE(68401960MK)                  
D&C YELLOW NO. 10(35SW5USQ3G)     
FD&C BLUE NO. 2(L06K8R7DQK)              
FD&C RED NO. 40(WZB9127XOA)            
FD&C YELLOW NO. 5(I753WB2F1M)                   
FD&C YELLOW NO. 6(H77VEI93A8)     
FERRIC OXIDE RED(1K09F3G675)             
FERRIC OXIDE YELLOW(EX438O2MRT)           
FERROSOFERRIC OXIDE(XM0M87F357)           
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)             
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)                 
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                    
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)                     
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)         
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                
HYPROMELLOSES(3NXW29V3WO)                  
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)                    
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                  
MAGNESIUM STEARATE(70097M6I30) 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)                     
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)           
POLYDEXTROSE(VH2XOU12IE)               
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                 
POLYETHYLENE GLYCOL 400(B697894SGQ)                
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)                 
POLYETHYLENE GLYCOL 6000(30IQX730WE)                  
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)                     
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)              
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                   
POLYSORBATE 80(6OZP39ZG8H)         
POLYVINYL ALCOHOL(532B59J990)                   
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                   
POVIDONE K29/32(390RMW2PEQ)                     
POVIDONE K30(U725QWY32X)            
POVIDONE K90(RDH86HJV5Z)           
POVIDONE(FZ989GH94E)                 
POVIDONE, UNSPECIFIED(FZ989GH94E)                    
PROPYLENE GLYCOL(6DC9Q167V3)             
PROPYLENE GLYCOL, (R)-(602HN5L69H)                     
SILICON DIOXIDE(ETJ7Z6XBU4)                   
SODIUM HYDROXIDE(55X04QC32I)                 
SODIUM LAURYL SULFATE(368GB5141J)                    
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                   
SORBIC ACID(X045WJ989B)                 
STARCH, CORN(O8232NY3SJ)               
TALC(7SEV7J4R1U)     
TITANIUM DIOXIDE(15FIX9V2JP) 
TRIACETIN(XHX3C3X673)