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Drug Product Composition: NCGC00024596-05

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$ API Ref.Price (USD/KG) : 361Xls

USFDA APPLICATION NUMBER - 17555 / DOSAGE - TABLET;ORAL - 25MG;250MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBIDOPA(UNII: MNX7R8C5VO)
(CARBIDOPA ANHYDROUS - UNII:KR87B45RGH)
CARBIDOPA ANHYDROUS25mg | 25mg | 10mg | 10mg | 25mg | 25mg
LEVODOPA(UNII: 46627O600J)
(LEVODOPA - UNII:46627O600J)
LEVODOPA250mg | 100mg | 100mg | 100mg | 100mg | 250mg

Inactive Ingredients

Ingredient Name
Merck Sharp & Dohme Corp.
NCS HealthCare of KY, Inc dba Vangard Labs
Actavis Pharma, Inc.
Avera McKennan Hospital
Cardinal Health
Lake Erie Medical DBA Quality Care Products LLC
Major Pharmaceuticals
Mayne Pharma Inc.
NuCare Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
REMEDYREPACK INC.
Golden State Medical Supply
Mylan Institutional Inc.
A-S Medication Solutions
Apotex Corp.
Bryant Ranch Prepack
Golden State Medical Supply, Inc.
McKesson Corporation dba SKY Packaging
Preferred Pharmaceuticals, Inc.
Teva Pharmaceuticals USA, Inc.
Unit Dose Services
ALUMINUM OXIDE(LMI26O6933)                   
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)           
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                    
CROSPOVIDONE(68401960MK)                    
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                  
D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6)                  
D&C YELLOW NO. 10(35SW5USQ3G)    
FD&C BLUE NO. 1(H3R47K3TBD)                    
FD&C BLUE NO. 2(L06K8R7DQK)        
FD&C BLUE NO. 2--ALUMINUM LAKE(4AQJ3LG584)                   
FD&C YELLOW NO. 6(H77VEI93A8)     
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                    
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)                    
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                    
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)                   
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)                    
MAGNESIUM PALMITOSTEARATE(R4OXA9G5BV)                    
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE 102(PNR0YF693Y)                    
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)        
sodium bicarbonate(8MDF5V39QO)                    
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)              
STARCH, CORN(O8232NY3SJ)