Deferasirox (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 90 mg

Rx Only NDC 69097-391-02

Deferasirox Film-coated Tablets

90 mg per Tablet

PHARMACIST:

Dispense the accompanying Medication Guide to each patient.

Bottles of 30 tablets

Deferasirox Film-coated Tablets
				Bottles of 30 tablets
(click image for full-size original)

Package Label – 90 mg

Package Label – 180 mg

Rx Only NDC 69097-392-02

Deferasirox Film-coated Tablets

180 mg per Tablet

PHARMACIST:

Dispense the accompanying Medication Guide to each patient.

Bottles of 30 tablets

Deferasirox Film-coated Tablets
				Bottles of 30 tablets
(click image for full-size original)

Package Label – 180 mg

Package Label – 360 mg

Rx Only NDC 69097-393-02

Deferasirox Film-coated Tablets

360 mg per Tablet

PHARMACIST:

Dispense the accompanying Medication Guide to each patient.

Bottles of 30 tablets

Deferasirox Film-coated Tablets
				Bottles of 30 tablets
(click image for full-size original)

Package Label – 360 mg

DEFERASIROX deferasirox tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-391
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLOXAMER 188
POVIDONE K30
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 8000
HYPROMELLOSE 2910 (6 MPA.S)
CROSPOVIDONE (15 MPA.S AT 5%)
Product Characteristics
Color PINK (light) Score no score
Shape OVAL (Biconvex) Size 11mm
Flavor Imprint Code C391
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-391-02 30 TABLET, COATED in 1 BOTTLE None
2 NDC:69097-391-20 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK (69097-391-19)
2 NDC:69097-391-19 10 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (69097-391-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211852 02/13/2020
DEFERASIROX deferasirox tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-392
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLOXAMER 188
POVIDONE K30
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 8000
HYPROMELLOSE 2910 (6 MPA.S)
CROSPOVIDONE (15 MPA.S AT 5%)
Product Characteristics
Color PINK (light) Score no score
Shape OVAL (Biconvex) Size 14mm
Flavor Imprint Code C392
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-392-02 30 TABLET, COATED in 1 BOTTLE None
2 NDC:69097-392-20 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK (69097-392-19)
2 NDC:69097-392-19 10 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (69097-392-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211852 06/14/2020
DEFERASIROX deferasirox tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-393
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLOXAMER 188
POVIDONE K30
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 8000
HYPROMELLOSE 2910 (6 MPA.S)
CROSPOVIDONE (15 MPA.S AT 5%)
Product Characteristics
Color PINK (light) Score no score
Shape OVAL (Biconvex) Size 17mm
Flavor Imprint Code C393
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-393-02 30 TABLET, COATED in 1 BOTTLE None
2 NDC:69097-393-20 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK (69097-393-19)
2 NDC:69097-393-19 10 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (69097-393-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211852 02/13/2020
Labeler — Cipla USA Inc. (078719707)
Registrant — Cipla Kurkumbh (917066446)
Establishment
Name Address ID/FEI Operations
Cipla Kurkumbh 917066446 MANUFACTURE (69097-391), MANUFACTURE (69097-392), MANUFACTURE (69097-393), API MANUFACTURE (69097-391), API MANUFACTURE (69097-392), API MANUFACTURE (69097-393)

Revised: 08/2020 Cipla USA Inc.

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