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Drug Product Composition: Lansoprazole

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$ API Ref.Price (USD/KG) : 93Xls

USFDA APPLICATION NUMBER - 20406 / DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lansoprazole(UNII: 0K5C5T2QPG)
(lansoprazole - UNII:0K5C5T2QPG)
lansoprazole30mg

Inactive Ingredients

Ingredient Name
Bryant Ranch Prepack
Lake Erie Medical DBA Quality Care Products LLC
REMEDYREPACK INC.
D&C RED NO. 28(767IP0Y5NH)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C GREEN NO. 3(3P3ONR6O1S)  
FD&C RED NO. 40(WZB9127XOA)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)  
HYDROXYPROPYL CELLULOSE (TYPE E)(66O7AQV0RT)  
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)  
hydroxypropyl cellulose(RFW2ET671P) 
hydroxypropyl cellulose, low substituted(2165RE0K14)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14)  
MAGNESIUM CARBONATE(0E53J927NA)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)  
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)
sucrose(C151H8M554)
TALC(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)