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Drug Product Composition: Omeprazole Magnesium

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$ API Ref.Price (USD/KG) : 229Xls

USFDA APPLICATION NUMBER - 21229 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM(UNII: 426QFE7XLK)
(OMEPRAZOLE - UNII:KG60484QX9)
OMEPRAZOLE20.6mg

Inactive Ingredients

Ingredient Name
L. Perrigo Company
REMEDYREPACK INC.
Fred's, Inc.
Wal-Mart Stores, Inc.
Aurohealth LLC
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Bi-Mart
DISCOUNT DRUG MART
Winco Foods, LLC.
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)       
CROSPOVIDONE (12 MPA.S AT 5%)(40UAA97IT9)       
CROSPOVIDONE (35 .MU.M)(40UAA97IT9)    
DEXTROSE, UNSPECIFIED FORM(IY9XDZ35W2)  
FD&C BLUE NO. 1(H3R47K3TBD)        
FD&C RED NO. 40(WZB9127XOA)        
FD&C YELLOW NO. 6(H77VEI93A8)        
FERRIC OXIDE RED(1K09F3G675) 
FERRIC OXIDE YELLOW(EX438O2MRT)  
GLYCERYL MONOSTEARATE(230OU9XXE4)
HYDROXYPROPYL CELLULOSE (45000 WAMW)(8VAB711C5E)  
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)  
HYDROXYPROPYL CELLULOSE(RFW2ET671P)        
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)  
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)  
HYPROMELLOSES(3NXW29V3WO)       
MAGNESIUM STEARATE(70097M6I30)
MEGLUMINE(6HG8UB2MUY)        
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)        
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)  
PARAFFIN(I9O0E3H2ZE)        
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)  
POLYETHYLENE GLYCOL 6000(30IQX730WE)        
POLYETHYLENE GLYCOL(3WJQ0SDW1A)        
POLYSORBATE 80(6OZP39ZG8H)
SILICON DIOXIDE(ETJ7Z6XBU4)  
SODIUM HYDROXIDE(55X04QC32I)  
SODIUM LAURYL SULFATE(368GB5141J)        
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
STARCH, CORN(O8232NY3SJ)  
SUCROSE(C151H8M554) 
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)