Deferasirox (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Deferasirox Tablets 90 mg

deferasirox-lab1
(click image for full-size original)

NDC 70700-269-30
RX ONLY
Deferasirox Tablets 90 mg 30 TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Deferasirox Tablets 180 mg

deferasirox-lab2
(click image for full-size original)

NDC 70700-270-30
RX ONLY
Deferasirox Tablets 180 mg 30 TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Deferasirox Tablets 360 mg

deferasirox-lab3
(click image for full-size original)

NDC 70700-271-30
RX ONLY
Deferasirox Tablets 360 mg 30 TABLETS

DEFERASIROX deferasirox tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-269
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE K30
POLOXAMER 188
TALC
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color BLUE (Light blue) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 90
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-269-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212995 01/02/2020
DEFERASIROX deferasirox tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-270
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE K30
POLOXAMER 188
TALC
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color BLUE (Light blue) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 180
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-270-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212995 06/15/2020
DEFERASIROX deferasirox tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-271
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
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE K30
POLOXAMER 188
TALC
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color BLUE (Dark blue) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 360
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-271-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212995 01/02/2020
Labeler — Xiromed, LLC (080228637)
Registrant — Piramal Healthcare UK Limited (345609965)
Establishment
Name Address ID/FEI Operations
Piramal Pharma Limited 862202793 ANALYSIS (70700-269), ANALYSIS (70700-270), ANALYSIS (70700-271), MANUFACTURE (70700-269), MANUFACTURE (70700-270), MANUFACTURE (70700-271), PACK (70700-269), PACK (70700-270), PACK (70700-271)

Revised: 12/2020 Xiromed, LLC

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