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Drug Product Composition: Loperamide/simeticone

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$ API Ref.Price (USD/KG) : 303Xls

USFDA APPLICATION NUMBER - 21855 / DOSAGE - CAPSULE;ORAL - 2MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE(UNII: 77TI35393C)
(LOPERAMIDE - UNII:6X9OC3H4II)
LOPERAMIDE HYDROCHLORIDE2mg

Inactive Ingredients

Ingredient Name
AmerisourceBergen (Good Neighbor Pharmacy) 46122
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
Best Choice (Valu Merchandisers Company)
Chain Drug Consortium, LLC
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Freds Inc
Good Sense (Geiss, Destin & Dunn, Inc.)
Hy-Vee
Lil' Drug Store Products, Inc.
McKesson (Health Mart)
P & L Development, LLC
Strategic Sourcing Services LLC
STRATEGIC SOURCING SERVICES, LLC
TARGET Corporation
TOP CARE (Topco Associates LLC)
Walgreens
Western Family Foods, Inc.
McKesson Contract Packaging
NCS HealthCare of KY, Inc dba Vangard Labs
PD-Rx Pharmaceuticals, Inc.
REMEDYREPACK INC.
Unit Dose Services
A-S Medication Solutions LLC
Bryant Ranch Prepack
Clinical Solutions Wholesale
NuCare Pharmaceuticals,Inc.
NuCare pharmceuticals,Inc.
Preferred Pharmaceuticals, Inc.
Lake Erie Medical DBA Quality Care Products LLC
BUTYLATED HYDROXYANISOLE(REK4960K2U)            
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                         
D&C YELLOW NO. 10(35SW5USQ3G)                           
DIMETHICONE(92RU3N3Y1O)                     
FD&C BLUE NO. 1(H3R47K3TBD)          
FD&C BLUE NO. 2(L06K8R7DQK)                           
FD&C RED NO. 40(WZB9127XOA)                           
FERRIC OXIDE RED(1K09F3G675)                   
FERRIC OXIDE YELLOW(EX438O2MRT)                   
FERROSOFERRIC OXIDE(XM0M87F357)                  
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000)(0K9R94573C)                            
GELATIN(2G86QN327L)    
GELATIN, UNSPECIFIED(2G86QN327L)                        
GLYCERIN(PDC6A3C0OX)            
GLYCERYL CAPRYLATE(TM2TZD4G4A)                            
GLYCERYL MONOCAPRYLATE(TM2TZD4G4A)             
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                 
MAGNESIUM STEARATE(70097M6I30)                 
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                            
POLYOXYL 40 HYDROGENATED CASTOR OIL(7YC686GQ8F)            
PROPYLENE GLYCOL(6DC9Q167V3)                           
SHELLAC(46N107B71O)                   
SILICON DIOXIDE(ETJ7Z6XBU4)                        
SODIUM LAURYL SULFATE(368GB5141J)                           
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                        
STARCH, CORN(O8232NY3SJ)                    
TITANIUM DIOXIDE(15FIX9V2JP)                 
WATER(059QF0KO0R)