Exjade (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

NDC 0078-0468-15 Rx only

EXJADE®
(deferasirox)

Tablets for Oral Suspension*

125 mg per tablet

PHARMACIST: Dispense with accompanyingMedication Guide to each patient.

DO NOT CHEW OR SWALLOW WHOLE

*Tablets MUST be dispersed in water,

orange or apple juice prior to ingestion.

NOVARTIS 30 Tablets

PRINCIPAL DISPLAY PANEL EXJADE ® (deferasirox) Tablets for Oral Suspension* 125 mg per tablet
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0469-15 Rx only

EXJADE®
(deferasirox)

Tablets for Oral Suspension*

250 mg per tablet

PHARMACIST: Dispense with accompanyingMedication Guide to each patient.

DO NOT CHEW OR SWALLOW WHOLE

*Tablets MUST be dispersed in water,

orange or apple juice prior to ingestion.

NOVARTIS 30 Tablets

PRINCIPAL DISPLAY PANEL EXJADE ® (deferasirox) Tablets for Oral Suspension* 250 mg per tablet
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0470-15 Rx only

EXJADE®
(deferasirox)

Tablets for Oral Suspension*

500 mg per tablet

PHARMACIST: Dispense with accompanyingMedication Guide to each patient.

DO NOT CHEW OR SWALLOW WHOLE

*Tablets MUST be dispersed in water,

orange or apple juice prior to ingestion.

NOVARTIS 30 Tablets

PRINCIPAL DISPLAY PANEL EXJADE ® (deferasirox) Tablets for Oral Suspension* 500 mg per tablet
(click image for full-size original)
EXJADE deferasirox tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0468
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFERASIROX (DEFERASIROX) DEFERASIROX 125 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SILICON DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (OFF-WHITE) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code J;125;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0468-15 30 TABLET, FOR SUSPENSION in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021882 11/30/2005
EXJADE deferasirox tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0469
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFERASIROX (DEFERASIROX) DEFERASIROX 250 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SILICON DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (OFF-WHITE) Score no score
Shape ROUND Size 15mm
Flavor Imprint Code J;250;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0469-15 30 TABLET, FOR SUSPENSION in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021882 11/30/2005
EXJADE deferasirox tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0470
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFERASIROX (DEFERASIROX) DEFERASIROX 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SILICON DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (OFF-WHITE) Score no score
Shape ROUND Size 20mm
Flavor Imprint Code J;500;NVR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0470-15 30 TABLET, FOR SUSPENSION in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021882 11/30/2005
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 08/2023 Novartis Pharmaceuticals Corporation

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