NDC Code(s) : 0179-0142-70
Packager : KAISER FOUNDATION HOSPITALS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lialdamesalamine TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0179-0142(NDC:54092-476)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESALAMINE(UNII: 4Q81I59GXC)
(MESALAMINE - UNII:4Q81I59GXC) 		MESALAMINE1.2 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
CARNAUBA WAX(UNII: R12CBM0EIZ)
STEARIC ACID(UNII: 4ELV7Z65AP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(UNII: 5KY68S2577)
Product Characteristics
Color RED (red), BROWN (brown) Score no score
Shape OVAL (OVAL) Size 20 mm
Flavor Imprint Code S476
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0179-0142-7030 in 1 BOX, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022000 12/06/2013

PRINCIPAL DISPLAY PANEL

lialda-2