NDC Code(s) : 57664-768-83, 57664-769-83, 57664-770-83
Packager : Sun Pharmaceutical Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DEFERASIROXDEFERASIROX 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(UNII: V8G4MOF2V9)
(DEFERASIROX - UNII:V8G4MOF2V9) 		DEFERASIROX90 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLOXAMER 188(UNII: LQA7B6G8JG)
POVIDONE K30(UNII: U725QWY32X)
HYPROMELLOSE 2910 (10000 MPA.S)(UNII: 0HO1H52958)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color blue (LIGHT BLUE) Score no score
Shape OVAL Size 11 mm
Flavor Imprint Code S102
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57664-768-8330 in 1 BOTTLE Type 0: Not a Combination Product01/02/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211641 01/02/2020
DEFERASIROXDEFERASIROX 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(UNII: V8G4MOF2V9)
(DEFERASIROX - UNII:V8G4MOF2V9) 		DEFERASIROX180 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLOXAMER 188(UNII: LQA7B6G8JG)
POVIDONE K30(UNII: U725QWY32X)
HYPROMELLOSE 2910 (10000 MPA.S)(UNII: 0HO1H52958)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color blue (MEDIUM BLUE) Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code S103
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57664-769-8330 in 1 BOTTLE Type 0: Not a Combination Product15/06/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211641 06/15/2020
DEFERASIROXDEFERASIROX 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(UNII: V8G4MOF2V9)
(DEFERASIROX - UNII:V8G4MOF2V9) 		DEFERASIROX360 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLOXAMER 188(UNII: LQA7B6G8JG)
POVIDONE K30(UNII: U725QWY32X)
HYPROMELLOSE 2910 (10000 MPA.S)(UNII: 0HO1H52958)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color blue (DARK BLUE) Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code S104
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57664-770-8330 in 1 BOTTLE Type 0: Not a Combination Product01/02/2020
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 Business Operations
ALKALOIDA Chemical Company Zrt. 643611692 manufacture(57664-768, 57664-769, 57664-770)

PRINCIPAL DISPLAY PANEL

Package Label – 90mg

Deferasirox 90mg

PRINCIPAL DISPLAY PANEL

Package Label-180mg

PDP-180mg

PRINCIPAL DISPLAY PANEL

Package Label – 360mg

PDP-360mg