NDC Code(s) : 69189-0252-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fosrenollanthanum carbonate TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0252(NDC:54092-252)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANTHANUM CARBONATE(UNII: 490D9F069T)
(LANTHANUM CATION (3+) - UNII:O7FU5X12W5) 		LANTHANUM CATION (3+)500 mg
Inactive Ingredients
Ingredient Name Strength
DEXTRATES(UNII: G263MI44RU)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white (white) Score no score
Shape ROUND (ROUND) Size 18 mm
Flavor Imprint Code S405;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-0252-11 in 1 DOSE PACK Type 0: Not a Combination Product03/03/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021468 03/03/2015

PRINCIPAL DISPLAY PANEL

Lanthanum Carbonate 500 mg chewable tablet