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Drug Product Composition: Esomeprazole

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

USFDA APPLICATION NUMBER - 204655 / DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9)
(ESOMEPRAZOLE - UNII:N3PA6559FT)
ESOMEPRAZOLE20mg

Inactive Ingredients

Ingredient Name
Chain Drug Consortium, LLC
DISCOUNT DRUG MART
Dolgencorp, LLC
Family Dollar, Inc.
Fred's, Inc.
Genomma Lab USA Inc
Harris Teeter
Sam's West Inc
Strategic Sourcing Services LLC
A-S Medication Solutions
Amerisource Bergen
Cardinal Health
CVS Pharmacy
DZA Brands LLC
Family Dollar Services Inc
H E B
Kmart Corporation
Kroger Company
L. Perrigo Company
Publix Super Markets Inc
Rugby Laboratories
Shopko Stores Operating Co., LLC
Wakefern Food Corporation
Wal-Mart Stores Inc
AMMONIA(5138Q19F1X)               
D&C RED NO. 28(767IP0Y5NH)                       
DEXTROSE, UNSPECIFIED FORM(IY9XDZ35W2)               
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 3(PN2ZH5LOQY)          
FD&C RED NO. 40(WZB9127XOA)                       
FERRIC OXIDE RED(1K09F3G675)         
FERRIC OXIDE YELLOW(EX438O2MRT)               
GELATIN(2G86QN327L)                   
GELATIN, UNSPECIFIED(2G86QN327L)     
GLYCERYL MONOSTEARATE(230OU9XXE4)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                       
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)               
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)     
HYPROMELLOSES(3NXW29V3WO)                   
MAGNESIUM CARBONATE(0E53J927NA)               
MAGNESIUM OXIDE(3A3U0GI71G)               
MAGNESIUM STEARATE(70097M6I30)         
MEGLUMINE(6HG8UB2MUY)          
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)               
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)                       
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                   
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)               
POLYSORBATE 80(6OZP39ZG8H)
PROPYLENE GLYCOL(6DC9Q167V3)               
SHELLAC(46N107B71O) 
SILICON DIOXIDE(ETJ7Z6XBU4)               
SODIUM LAURYL SULFATE(368GB5141J) 
STARCH, CORN(O8232NY3SJ)              
SUCROSE(C151H8M554)              
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)