NDC Code(s) : 69189-0497-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DRISDOLErgocalciferol CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0497(NDC:0024-0393)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ergocalciferol(UNII: VS041H42XC)
(Ergocalciferol - UNII:VS041H42XC) 		Ergocalciferol1.25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C Blue No. 1(UNII: H3R47K3TBD)
FD&C Yellow No. 5(UNII: I753WB2F1M)
Gelatin(UNII: 2G86QN327L)
Glycerin(UNII: PDC6A3C0OX)
Soybean Oil(UNII: 241ATL177A)
Product Characteristics
Color GREEN Score no score
Shape CAPSULE (oval shaped) Size 13 mm
Flavor Imprint Code W;D;92
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-0497-11 in 1 DOSE PACK Type 0: Not a Combination Product05/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA003444 02/05/2016

PRINCIPAL DISPLAY PANEL

Ergocalciferol 50,000 IU capsule