Deferasirox (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

Package Label – 125 mg Tablets for Oral Suspension

NDC 69452-159-13

Deferasirox Tablets for Oral Suspension*

125 mg per tablet

DO NOT CHEW OR SWALLOW WHOLE
*Tablets MUST be dispersed in water,
orange or apple juice prior to ingestion.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Tablets

BIONPHARMA

125 mg Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Package Label – 250 mg Tablets for Oral Suspension

NDC 69452-160-13

Deferasirox Tablets for Oral Suspension*

250 mg per tablet

DO NOT CHEW OR SWALLOW WHOLE

*Tablets MUST be dispersed in water,
orange or apple juice prior to ingestion.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only 30 Tablets

BIONPHARMA

250 mg Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Package Label – 500 mg Tablets for Oral Suspension

BIONPHARMA

NDC 69452-161-13

Deferasirox Tablets for Oral Suspension*

500 mg per tablet

DO NOT CHEW OR SWALLOW WHOLE
*Tablets MUST be dispersed in water,
orange or apple juice prior to ingestion.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Tablets

BIONPHARMA

500 mg Label
(click image for full-size original)
DEFERASIROX deferasirox tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-159
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
SILICON DIOXIDE
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM LAURYL SULFATE
Product Characteristics
Color white (off-white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code D1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-159-13 30 TABLET, FOR SUSPENSION in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210920 12/14/2018
DEFERASIROX deferasirox tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-160
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
SILICON DIOXIDE
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM LAURYL SULFATE
Product Characteristics
Color white (off-white) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code D2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-160-13 30 TABLET, FOR SUSPENSION in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210920 12/14/2018
DEFERASIROX deferasirox tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-161
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
SILICON DIOXIDE
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM LAURYL SULFATE
Product Characteristics
Color white (off-white) Score no score
Shape ROUND Size 16mm
Flavor Imprint Code D3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-161-13 30 TABLET, FOR SUSPENSION in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210920 12/14/2018
Labeler — Bionpharma Inc. (079637826)
Registrant — Bionpharma Inc. (079637826)
Establishment
Name Address ID/FEI Operations
Bluepharma Indústria Farmacêutica, S.A. 449909329 manufacture (69452-159), manufacture (69452-160), manufacture (69452-161)

Revised: 11/2019 Bionpharma Inc.

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