NDC Code(s) : 50474-920-90, 50474-921-05
Packager : UCB, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Xyzallevocetirizine dihydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-920
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
levocetirizine dihydrochloride(UNII: SOD6A38AGA)
(levocetirizine - UNII:6U5EA9RT2O) 		levocetirizine dihydrochloride5 mg
Inactive Ingredients
Ingredient Name Strength
microcrystalline cellulose(UNII: OP1R32D61U)
lactose monohydrate(UNII: EWQ57Q8I5X)
silicon dioxide(UNII: ETJ7Z6XBU4)
magnesium stearate(UNII: 70097M6I30)
hypromellose, unspecified(UNII: 3NXW29V3WO)
titanium dioxide(UNII: 15FIX9V2JP)
polyethylene glycol 400(UNII: B697894SGQ)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 8 mm
Flavor Imprint Code Y
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50474-920-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/09/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022064 08/09/2007 01/19/2019
Xyzallevocetirizine dihydrochloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-921
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
levocetirizine dihydrochloride(UNII: SOD6A38AGA)
(levocetirizine - UNII:6U5EA9RT2O) 		levocetirizine dihydrochloride0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium acetate(UNII: 4550K0SC9B)
acetic acid(UNII: Q40Q9N063P)
maltitol(UNII: D65DG142WK)
glycerin(UNII: PDC6A3C0OX)
methylparaben(UNII: A2I8C7HI9T)
propylparaben(UNII: Z8IX2SC1OH)
saccharin(UNII: FST467XS7D)
triacetin(UNII: XHX3C3X673)
.alpha.-tocopherol, dl-(UNII: 7QWA1RIO01)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50474-921-051 in 1 CARTON 04/02/2008
1148 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022157 04/02/2008 06/08/2018

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label

NDC 50474-920-90
90 tablets

XYZAL ®
(levocetirizine
dihydrochloride)

5 mg per tablet
For oral administration

ucb

Rx Only

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

NDC 50474-921-05

1 x 5 oz. (148 mL)
polypropylene bottle

XYZAL®
(levocetirizine dihydrochloride)
oral solution
2.5 mg/5 mL (0.5 mg/mL)

Rx Only

ucb

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton