NDC Code(s) : 55154-5254-9
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DigoxinDIGOXIN TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5254(NDC:0115-9811)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN(UNII: 73K4184T59)
(DIGOXIN - UNII:73K4184T59) 		DIGOXIN125 ug
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
Product Characteristics
Color YELLOW (light yellow) Score 2 pieces
Shape ROUND (convex) Size 6 mm
Flavor Imprint Code 981
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-5254-930 in 1 BLISTER PACK Type 0: Not a Combination Product01/12/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078556 12/01/2009 10/15/2013

PRINCIPAL DISPLAY PANEL

Digoxin

125 mcg (0.125 mg)

tablets, USP

Card Label

PRINCIPAL DISPLAY PANEL

Digoxin

125 mcg (0.125 mg)

Tablets, USP

Qty 30

Lidding label