Deferasirox (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 125 mg

NDC 46708-324-30
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.
Alembic
Rx only 30 Tablets

30 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 250 mg

NDC 46708-325-30
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.
Alembic
Rx only
30 Tablets

30 Tablets
(click image for full-size original)

30 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 500 mg

NDC 46708-326-30
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.
Alembic
Rx only 30 Tablets

30 Tablets
(click image for full-size original)
DEFERASIROX deferasirox tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-324
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
SODIUM STARCH GLYCOLATE TYPE A POTATO
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
SODIUM LAURYL SULFATE
POVIDONE K30
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code L461
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-324-30 30 TABLET, FOR SUSPENSION in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210060 11/21/2019
DEFERASIROX deferasirox tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-325
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
SODIUM STARCH GLYCOLATE TYPE A POTATO
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
SODIUM LAURYL SULFATE
POVIDONE K30
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 14mm
Flavor Imprint Code L462
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-325-30 30 TABLET, FOR SUSPENSION in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210060 11/21/2019
DEFERASIROX deferasirox tablet, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-326
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
SODIUM STARCH GLYCOLATE TYPE A POTATO
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
SODIUM LAURYL SULFATE
POVIDONE K30
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 18mm
Flavor Imprint Code L463
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-326-30 30 TABLET, FOR SUSPENSION in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210060 11/21/2019
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-324), MANUFACTURE (46708-325), MANUFACTURE (46708-326)

Revised: 11/2019 Alembic Pharmaceuticals Limited

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