NDC Code(s) : 69097-550-53, 69097-560-53, 69097-570-53
Packager : Cipla USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Deferasirox Deferasirox GRANULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-550
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFERASIROX(UNII: V8G4MOF2V9)
(DEFERASIROX - UNII:V8G4MOF2V9) 		DEFERASIROX90 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE 101(UNII: 7T9FYH5QMK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSPOVIDONE(UNII: 2S7830E561)
POVIDONE K30(UNII: U725QWY32X)
POLOXAMER 188(UNII: LQA7B6G8JG)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (white to off white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-550-5330 in 1 CARTON 23/02/2022
11 in 1 PACKET Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215026 02/23/2022
Deferasirox Deferasirox GRANULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-560
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFERASIROX(UNII: V8G4MOF2V9)
(DEFERASIROX - UNII:V8G4MOF2V9) 		DEFERASIROX180 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE 101(UNII: 7T9FYH5QMK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSPOVIDONE(UNII: 2S7830E561)
POVIDONE K30(UNII: U725QWY32X)
POLOXAMER 188(UNII: LQA7B6G8JG)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (white to off white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-560-5330 in 1 CARTON 23/02/2022
11 in 1 PACKET Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215026 02/23/2022
Deferasirox Deferasirox GRANULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-570
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFERASIROX(UNII: V8G4MOF2V9)
(DEFERASIROX - UNII:V8G4MOF2V9) 		DEFERASIROX360 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE 101(UNII: 7T9FYH5QMK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CROSPOVIDONE(UNII: 2S7830E561)
POVIDONE K30(UNII: U725QWY32X)
POLOXAMER 188(UNII: LQA7B6G8JG)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (white to off white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-570-5330 in 1 CARTON 23/02/2022
11 in 1 PACKET Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215026 02/23/2022

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
Cipla Limited- Kurkumbh 917066446 API MANUFACTURE(69097-550, 69097-560, 69097-570), MANUFACTURE(69097-550, 69097-560, 69097-570)

PRINCIPAL DISPLAY PANEL

NDC 69097-550-53

Deferasirox Oral Granules, 90 mg

Rx Only

Cipla USA, Inc.

Carton Label (30 Sachets in 1 Carton)

90 mg

NDC 69097-560-53

Deferasirox Oral Granules, 180 mg

Rx Only

Cipla USA, Inc.

Carton Label (30 Sachets in 1 Carton)

90 mg

NDC 69097-570-53

Deferasirox Oral Granules, 360 mg

Rx Only

Cipla USA, Inc.

Carton Label (30 Sachets in 1 Carton)

90 mg