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Drug Product Composition: CAS-151767-02-1

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$ API Ref.Price (USD/KG) : 1,131Xls

USFDA APPLICATION NUMBER - 20830 / DOSAGE - TABLET, CHEWABLE;ORAL - EQ 5MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MONTELUKAST SODIUM(UNII: U1O3J18SFL)
(MONTELUKAST - UNII:MHM278SD3E)
MONTELUKAST SODIUM4mg | 5mg | 10mg

Inactive Ingredients

Ingredient Name
Apotex Corp
A-S Medication Solutions
A-S Medication Solutions LLC
ACETRIS HEALTH, LLC
ASE Direct, Inc.
Bionpharma Inc.
Bryant Ranch Prepack
Cardinal Health
Graviti Pharmaceuticals Private Limited
Jubilant Cadista Pharmaceuticals Inc.
Lake Erie Medical DBA Quality Care Products LLC
Merck Sharp & Dohme Corp.
Method Pharmaceuticals, LLC
Mylan Pharmaceuticals Inc.
NuCare Pharmaceuticals,Inc.
NuCare Pharmaceuticals,Inc.
Par Pharmaceutical
PD-Rx Pharmaceuticals, Inc.
Physicians Total Care, Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Proficient Rx LP
REMEDYREPACK INC.
Teva Pharmaceuticals USA, Inc.
{Preferred Pharmaeutials INC.
Hikma Pharmaceuticals USA Inc.
ANHYDROUS LACTOSE(3SY5LH9PMK)                         
ASPARTAME(Z0H242BBR1) 
CARNAUBA WAX(R12CBM0EIZ)                   
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)         
CHERRY(BUC5I9595W)               
COPOVIDONE K25-31(D9C330MD8B)                         
croscarmellose sodium(M28OL1HH48)   
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)            
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                      
Hydroxypropyl Cellulose (1600000 Wamw)(RFW2ET671P)               
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                       
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)                         
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)                        
HYPROMELLOSE 2208 (15000 CPS)(Z78RG6M2N2)                         
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                         
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                     
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                        
HYPROMELLOSES(3NXW29V3WO)                      
LACTOSE MONOHYDRATE(EWQ57Q8I5X)             
MAGNESIUM STEARATE(70097M6I30)
MALTODEXTRIN(7CVR7L4A2D)                       
mannitol(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                 
POLYDEXTROSE(VH2XOU12IE)                         
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                         
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                         
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                         
SILICON DIOXIDE(ETJ7Z6XBU4)                       
SODIUM LAURYL SULFATE(368GB5141J)                      
SODIUM PHOSPHATE, TRIBASIC(A752Q30A6X)                         
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                      
STARCH, CORN(O8232NY3SJ)                       
Strawberry(4J2TY8Y81V)                         
SUCRALOSE(96K6UQ3ZD4)                         
TALC(7SEV7J4R1U)                         
TITANIUM DIOXIDE(15FIX9V2JP)           
TRIACETIN(XHX3C3X673)