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Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lansoprazole (UNII: 0K5C5T2QPG) (lansoprazole - UNII:0K5C5T2QPG) lansoprazole 30 mg
Inactive Ingredients
Ingredient Name Strength
sucrose (UNII: C151H8M554)
methacrylic acid - ethyl acrylate copolymer (1:1) type A (UNII: NX76LV5T8J)
hydroxypropyl cellulose, low substituted (UNII: 2165RE0K14)
starch, corn (UNII: O8232NY3SJ)
magnesium carbonate (UNII: 0E53J927NA)
talc (UNII: 7SEV7J4R1U)
polyethylene glycols (UNII: 3WJQ0SDW1A)
titanium dioxide (UNII: 15FIX9V2JP)
polysorbate 80 (UNII: 6OZP39ZG8H)
hydroxypropyl cellulose (UNII: RFW2ET671P)
silicon dioxide (UNII: ETJ7Z6XBU4)
D&C Red No. 28 (UNII: 767IP0Y5NH)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Red No. 40 (UNII: WZB9127XOA)
Product Characteristics
Color PINK (Opaque) , BLACK (Opaque) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code TAP;PREVACID;30
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49999-480-30 30 in 1 BOTTLE
2 NDC:49999-480-60 60 in 1 BOTTLE
3 NDC:49999-480-90 90 in 1 BOTTLE
4 NDC:49999-480-00 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020406 05/10/1995
Labeler - Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Business Operations
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 831276758 repack(49999-480)
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