NDC Code(s) : 61786-898-02
Packager : REMEDYREPACK INC.

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:61786-898(NDC:49884-494)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN(UNII: 73K4184T59)
(DIGOXIN - UNII:73K4184T59) 		DIGOXIN0.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, POTATO(UNII: 8I089SAH3T)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code LANOXIN;X3A
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-898-0230 in 1 BLISTER PACK Type 0: Not a Combination Product21/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020405 09/21/2016 02/27/2017

PRINCIPAL DISPLAY PANEL

DRUG: DIGOXIN

GENERIC: DIGOXIN

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-898-02

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 7 mm

IMPRINT: LANOXIN;X3A

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DIGOXIN 0.25mg in 1

INACTIVE INGREDIENT(S):

  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • STARCH, CORN
  • STARCH, POTATO

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