Deferasirox (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Deferasirox Tablets 90 mg-30’s count container label

90mg-30count
(click image for full-size original)

Deferasirox Tablets 180 mg-30’s count container label

180mg-30count
(click image for full-size original)

Deferasirox Tablets 360 mg-30’s count container label

360mg-30count
(click image for full-size original)
DEFERASIROX deferasirox tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-011
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
MICROCRYSTALLINE CELLULOSE
POLOXAMER 188
POVIDONE
SODIUM STEARYL FUMARATE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 6000
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (biconvex) Size 11mm
Flavor Imprint Code V;56
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-011-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214341 05/14/2021
DEFERASIROX deferasirox tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-012
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
MICROCRYSTALLINE CELLULOSE
POLOXAMER 188
POVIDONE
SODIUM STEARYL FUMARATE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 6000
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (biconvex) Size 14mm
Flavor Imprint Code V;57
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-012-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214341 05/14/2021
DEFERASIROX deferasirox tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-013
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
MICROCRYSTALLINE CELLULOSE
POLOXAMER 188
POVIDONE
SODIUM STEARYL FUMARATE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 6000
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (biconvex) Size 17mm
Flavor Imprint Code V;58
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-013-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214341 05/14/2021
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Annora Pharma Private Limited 650980746 analysis (31722-011), analysis (31722-012), analysis (31722-013), manufacture (31722-011), manufacture (31722-012), manufacture (31722-013)

Revised: 06/2021 Camber Pharmaceuticals, Inc.

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