DEFERASIROX (Page 11 of 11)

PRINCIPAL DISPLAY PANEL

Package Label – 90mg

Deferasirox 90mg
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Package Label-180mg

PDP-180mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Package Label – 360mg

PDP-360mg
(click image for full-size original)
DEFERASIROX
deferasirox tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-768
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFERASIROX (DEFERASIROX) DEFERASIROX 90 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLOXAMER 188
POVIDONE K30
HYPROMELLOSE 2910 (10000 MPA.S)
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL 4000
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (LIGHT BLUE) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code S102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-768-83 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211641 01/02/2020
DEFERASIROX
deferasirox tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-769
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFERASIROX (DEFERASIROX) DEFERASIROX 180 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLOXAMER 188
POVIDONE K30
HYPROMELLOSE 2910 (10000 MPA.S)
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL 4000
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (MEDIUM BLUE) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code S103
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-769-83 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211641 06/15/2020
DEFERASIROX
deferasirox tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-770
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFERASIROX (DEFERASIROX) DEFERASIROX 360 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLOXAMER 188
POVIDONE K30
HYPROMELLOSE 2910 (10000 MPA.S)
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL 4000
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (DARK BLUE) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code S104
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-770-83 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211641 01/02/2020
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
ALKALOIDA Chemical Company Zrt. 643611692 MANUFACTURE (57664-768), MANUFACTURE (57664-769), MANUFACTURE (57664-770)

Revised: 06/2020 Sun Pharmaceutical Industries, Inc.

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