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Drug Product Composition: Esomeprazole

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$ API Ref.Price (USD/KG) : 204Xls

USFDA APPLICATION NUMBER - 21153 / DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9)
(ESOMEPRAZOLE MAGNESIUM - UNII:R6DXU4WAY9)
ESOMEPRAZOLE MAGNESIUM20mg | 40mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
A-S Medication Solutions LLC
American Health Packaging
Ascend Laboratories, LLC
AstraZeneca Pharmaceuticals LP
Avera McKennan Hospital
Bryant Ranch Prepack
Camber Pharmaceuticals, Inc.
Cardinal Health
Clinical Solutions Wholesale
DirectRX
Direct_Rx
Dr. Reddy's Laboratories Inc
Dr. Reddy's Laboratories Limited
Lake Erie Medical DBA Quality Care Products LLC
NorthStar Rx LLC
NuCare Pharmaceuticals,Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
REMEDYREPACK INC.
St. Mary's Medical Park Pharmacy
Sunshine Lake Pharma Co., Ltd.
Unit Dose Services
Biocon Pharma Inc.,
Cisen Pharmaceutical Co., Ltd.
Graviti Pharmaceuticals Private Limited
Mylan Institutional Inc.
NCS HealthCare of KY, Inc dba Vangard Labs
Quallent Pharmaceuticals Health LLC
Quality Care Products, LLC
Torrent Pharmaceuticals Limited
AMTA LABS LIMITED
CSPC Ouyi Pharmaceutical Co., Ltd.
DIRECT RX
Glenmark Pharmaceuticals Inc., USA
Mullan Pharmaceutical Inc.
Proficient Rx LP
PureTek Corporation
Torrent Pharmaceuticals Limite
ALCOHOL(3K9958V90M)                
ALCOHOL, X-RAY EXPOSED (1000 RAD)(6PRJ93602P)                                      
Ammonia(5138Q19F1X)                   
ANHYDROUS CITRIC ACID(XF417D3PSL)                                     
ANHYDROUS DEXTROSE(5SL0G7R0OK)                                     
BEET(N487KM8COK)                                
Butyl Alcohol(8PJ61P6TS3)               
COPOVIDONE K25-31(D9C330MD8B)                                      
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                                     
D&C RED NO. 28(767IP0Y5NH)                          
D&C YELLOW NO. 10(35SW5USQ3G)                              
DEXTROSE(IY9XDZ35W2)                                     
DEXTROSE, UNSPECIFIED FORM(IY9XDZ35W2)                                     
Dimethicone(92RU3N3Y1O)                                     
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)                                     
ETHYLCELLULOSES(7Z8S9VYZ4B)                                 
FD&C BLUE NO. 1(H3R47K3TBD)           
FD&C RED NO. 3(PN2ZH5LOQY)                                     
FD&C RED NO. 40(WZB9127XOA)                      
FERRIC OXIDE YELLOW(EX438O2MRT)                       
Ferrosoferric Oxide(XM0M87F357)                    
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000)(0K9R94573C)                                      
GELATIN(2G86QN327L)           
GELATIN, UNSPECIFIED(2G86QN327L)                        
GLYCERYL CAPRYLOCAPRATE(U72Q2I8C85)                                  
GLYCERYL COCOATE(WVK1CT5994)                                   
GLYCERYL MONO AND DICAPRYLOCAPRATE(U72Q2I8C85)                                  
GLYCERYL MONO AND DIPALMITOSTEARATE(KC98RO82HJ)                                 
GLYCERYL MONOSTEARATE(230OU9XXE4)             
GLYCERYL STEARATE SE(FCZ5MH785I)                               
HYDROXYPROPYL CELLULOSE (110000 WAMW)(5Y0974F5PW)                                  
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                                      
HYDROXYPROPYL CELLULOSE (1200000 WAMW)(U3JF91U133)                                      
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                            
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)                                   
Hydroxypropyl Cellulose (Type H)(RFW2ET671P)                                
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                                    
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)                                   
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)                                    
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)                                   
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                             
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                                      
HYPROMELLOSE(3NXW29V3WO)                                      
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                           
HYPROMELLOSES(3NXW29V3WO)                           
ISOPROPYL ALCOHOL(ND2M416302)               
MAGNESIUM CARBONATE(0E53J927NA)                                   
MAGNESIUM OXIDE(3A3U0GI71G)                          
MAGNESIUM STEARATE(70097M6I30)           
MANNITOL(3OWL53L36A)                                 
MEGLUMINE(6HG8UB2MUY)                             
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)                  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)                               
METHACRYLIC ACID(1CS02G8656)                   
METHYL ALCOHOL(Y4S76JWI15)                               
METHYLENE CHLORIDE(588X2YUY0A)                               
POLOXAMER 188(LQA7B6G8JG)                             
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                                      
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                                 
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                                 
POLYSORBATE 80(6OZP39ZG8H)         
POTASSIUM HYDROXIDE(WZH3C48M4T)             
POTASSIUM SORBATE(1VPU26JZZ4)                                     
POVIDONE K30(U725QWY32X)                                   
POVIDONE K90(RDH86HJV5Z)                               
POVIDONE(FZ989GH94E)                                 
POVIDONE, UNSPECIFIED(FZ989GH94E)                                  
POVIDONES(FZ989GH94E)                                
PROPYLENE GLYCOL(6DC9Q167V3)         
SHELLAC(46N107B71O)      
SILICON DIOXIDE(ETJ7Z6XBU4)                            
SODIUM BICARBONATE(8MDF5V39QO)                                     
SODIUM HYDROXIDE(55X04QC32I)                        
SODIUM LAURYL SULFATE(368GB5141J)                   
STARCH, CORN(O8232NY3SJ)                       
SUCROSE(C151H8M554)             
TALC(7SEV7J4R1U)  
TITANIUM DIOXIDE(15FIX9V2JP)  
TRIETHYL CITRATE(8Z96QXD6UM)  
WATER BUFFALO, COOKED(RM3G76I0A1)                                      
WATER(059QF0KO0R)