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Drug Product Composition: Loratadine-d4

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$ API Ref.Price (USD/KG) : 333Xls

USFDA APPLICATION NUMBER - 20470 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG;240MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE(UNII: 7AJO3BO7QN)
(LORATADINE - UNII:7AJO3BO7QN)
LORATADINE10mg
PSEUDOEPHEDRINE SULFATE(UNII: Y9DL7QPE6B)
(PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
PSEUDOEPHEDRINE SULFATE240mg

Inactive Ingredients

Ingredient Name
Bryant Ranch Prepack
REMEDYREPACK INC.
Actavis Pharma, Inc.
Bayer HealthCare LLC.
Costco Wholesale Corporation
L Perrigo Company
TOP CARE (Topco Associates LLC)
HyVee Inc
Meijer Distribution Inc
Perrigo New York Inc
Walgreen Company
CALCIUM CARBONATE(H0G9379FGK)         
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)          
CANDELILLA WAX(WL0328HX19)      
CARNAUBA WAX(R12CBM0EIZ)          
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)         
ETHYLCELLULOSES(7Z8S9VYZ4B)         
FERROSOFERRIC OXIDE(XM0M87F357)
GLYCERYL MONOSTEARATE(230OU9XXE4)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)          
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)          
HYDROXYPROPYL CELLULOSE(RFW2ET671P)          
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)        
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)        
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)       
HYPROMELLOSES(3NXW29V3WO)   
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)          
POLYETHYLENE GLYCOL 400(B697894SGQ)        
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)        
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)         
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)    
POLYSORBATE 80(6OZP39ZG8H)  
POVIDONE(FZ989GH94E)          
POVIDONE, UNSPECIFIED(FZ989GH94E)          
POVIDONES(FZ989GH94E)         
PROPYLENE GLYCOL(6DC9Q167V3) 
SHELLAC(46N107B71O)         
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM ALGINATE(C269C4G2ZQ)         
SODIUM CITRATE(1Q73Q2JULR)         
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)          
SODIUM LAURYL SULFATE(368GB5141J)  
STARCH, CORN(O8232NY3SJ)         
STARCH, PREGELATINIZED CORN(O8232NY3SJ)          
SUCROSE(C151H8M554)          
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)