mpanies.
© AstraZeneca 2016
For more information, go to WWW.ZURAMPIC.COM or call 1-800-236-9933.
This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: January 201
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 0310-1475-05 5 Tablets
ZURAMPIC®
lesinurad tablets
200 mg
Dispense the accompanying Medication Guide to each patient.
Rx only
PROFESSIONAL SAMPLE-NOT FOR SALE
ZURAMPIC 200 mg 5 Tablets
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 0310-1475-30 30 Tablets
ZURAMPIC®
lesinurad tablets
200 mg
Dispense the accompanying Medication Guide to each patient.
Rx only
ZURAMPIC 200 mg 30 Tablets Bottle Label
INGREDIENTS AND APPEARANCE
ZURAMPIC
lesinurad tablet, film coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-1475
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
LESINURAD (UNII: 09ERP08I3W) (LESINURAD - UNII:09ERP08I3W) LESINURAD 200 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
Color BLUE Score no score
Shape OVAL Size 13mm
Flavor Imprint Code LES200
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0310-1475-05 5 in 1 BOTTLE; Type 0: Not a Combination Product 10/03/2016
2 NDC:0310-1475-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/11/2016
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207988 08/11/2016
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=92d614a3-760d-492c-930d-22f91ff016b1 |
