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Drug Product Composition: Omeprazole

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$ API Ref.Price (USD/KG) : 51Xls

USFDA APPLICATION NUMBER - 22032 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - 20MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE(UNII: KG60484QX9)
(OMEPRAZOLE - UNII:KG60484QX9)
OMEPRAZOLE20mg

Inactive Ingredients

Ingredient Name
Shopko Stores Operating Co., LLC
Supervalu Inc
7-Eleven
Cardinal Health
Dexcel Ltd.
Dexcel Pharma Technologies Ltd.
DZA Brands LLC
Genomma Lab USA, Inc.
Gericare Pharmaceuticals
Harmon Stores Inc.
Humana Pharmacy, Inc.
HyVee Inc
Kinray
Kmart Corporation
Lidl US LLC
Meijer Distribution Inc
REMEDYREPACK INC.
Save-A-Lot Food Stores Ltd
Wakefern Food Corporation
BENZYL ALCOHOL(LKG8494WBH)                 
CARNAUBA WAX(R12CBM0EIZ)
Ethanolamine(5KV86114PT)                 
FD&C BLUE NO. 2(L06K8R7DQK)                 
FERRIC OXIDE RED(1K09F3G675) 
FERRIC OXIDE YELLOW(EX438O2MRT) 
Hypromellose Acetate Succinate 12070923 (3 MM2/S)(36BGF0E889)                 
Hypromellose(3NXW29V3WO)                  
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                 
HYPROMELLOSES(3NXW29V3WO)   
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MENTHOL(L7T10EIP3A)                  
MENTHOL, UNSPECIFIED FORM(L7T10EIP3A)                  
MONOETHANOLAMINE(5KV86114PT) 
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                 
PROPYLENE GLYCOL(6DC9Q167V3) 
SODIUM LAURYL SULFATE(368GB5141J)
Sodium Starch Glycolate Type A Potato(5856J3G2A2)                 
SODIUM STEARATE(QU7E2XA9TG)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
SUCRALOSE(96K6UQ3ZD4)                 
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)                 
Triethyl Citrate(8Z96QXD6UM)