Jantoven (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Jantoven

GENERIC: Warfarin Sodium

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-614-02

ACTIVE INGREDIENT(S):

  • Warfarin Sodium 6mg in 1

INACTIVE INGREDIENT(S):

  • FD&C BLUE NO. 1
  • FERRIC OXIDE YELLOW
  • FERROSOFERRIC OXIDE
  • lactose monohydrate
  • magnesium stearate
  • povidone
  • starch, corn

COLOR: turquoise

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 9 mm

IMPRINT: WRF;6;832

PACKAGING: 30 in 1 BLISTER PACK

MM2
(click image for full-size original)
MM3
(click image for full-size original)
JANTOVEN warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-614(NDC:0832-1217)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin Sodium (WARFARIN) Warfarin Sodium 6 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
lactose monohydrate
magnesium stearate
povidone
starch, corn
Product Characteristics
Color turquoise Score 2 pieces
Shape ROUND (TABLET) Size 9mm
Flavor Imprint Code WRF;6;832
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52125-614-02 30 TABLET (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040416 05/29/2013
Labeler — REMEDYREPACK INC. (829572556)

Revised: 05/2013 REMEDYREPACK INC.

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