NDC Code(s) : 68621-0027-1, 68621-0028-1, 68621-0029-1
Packager : Catalent Germany Schorndorf GmbH

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Jadenudeferasirox GRANULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68621-0027
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 2S7830E561)
POVIDONE K30(UNII: U725QWY32X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLOXAMER 188(UNII: LQA7B6G8JG)
Product Characteristics
Color white (White to almost white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68621-0027-130 in 1 CARTON 18/05/2017
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
Approved Drug Product Manufactured Under Contract NDA207968 05/18/2017
Jadenudeferasirox GRANULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68621-0028
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 2S7830E561)
POVIDONE K30(UNII: U725QWY32X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLOXAMER 188(UNII: LQA7B6G8JG)
Product Characteristics
Color white (White to almost white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68621-0028-130 in 1 CARTON 18/05/2017
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
Approved Drug Product Manufactured Under Contract NDA207968 05/18/2017
Jadenudeferasirox GRANULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68621-0029
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
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSPOVIDONE(UNII: 2S7830E561)
POVIDONE K30(UNII: U725QWY32X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLOXAMER 188(UNII: LQA7B6G8JG)
Product Characteristics
Color white (White to almost white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68621-0029-130 in 1 CARTON 18/05/2017
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
Approved Drug Product Manufactured Under Contract NDA207968 05/18/2017

PRINCIPAL DISPLAY PANEL

Package Label – 90 mg

Rx Only NDC 0078-0727-15

Jadenu ® Sprinkle (deferasirox)

Oral Granules

90 mg

Each sachet contains 162 mg granule equivalent to 90 mg deferasirox

Contains 30 sachets

Novartis

Jadenu-carton-label-90

PRINCIPAL DISPLAY PANEL

Package Label – 180 mg

Rx Only NDC 0078-0713-15

Jadenu ® Sprinkle (deferasirox)

Oral Granules

180 mg

Each sachet contains 324 mg granule equivalent to 180 mg deferasirox

Contains 30 sachets

Novartis

Jadenu-carton-label-180

PRINCIPAL DISPLAY PANEL

Package Label – 360 mg

Rx Only NDC 0078-0720-15

Jadenu ® Sprinkle (deferasirox)

Oral Granules

360 mg

Each sachet contains 648 mg granule equivalent to 360 mg deferasirox

Contains 30 sachets

Novartis

Jadenu-carton-label-360

PRINCIPAL DISPLAY PANEL

SHIIPING LABEL

Product: Jadenu GRU 90mg ALU (X30) US

Material code: 736126

Batch:

MFD:

ExP:

Quantity: 60 finished packs per shipper

NSC: 9A

Tempcontrol: Transport and intermediate storage not above +30ºC

Local Material: PCD460429CATALENT, CH

Handling Unite ID:

Catalent Order Number:

Customer PO Number:

Customer: Novartis Pharma

Jadenu-shipper-label-90

PRINCIPAL DISPLAY PANEL

SHIPPING LABEL

JADENU GRU 180mg ALU (X30) US

Material Code: 736127

Batch:

MFD:

EXP:

Quantity: 60 finished packs per shipper

NSC: 9A

Tempcontrol: Transport and Intermediate storage not above +30ºC

Local Material: PCD460432CATALENT, CH

Handling Unit iD:

Catalent Order number:

Customer PO Number:

Jadenu-shipper-label-180

PRINCIPAL DISPLAY PANEL

SHIPPING LABEL

Product: Jadenu GRU 360mg ALU (X30) US

Material Code: 736128

Batch:

MFD:

Quantity: 60 finished packs per shipper

NSC:9A

Tempcontrol: Transport and intermediate storage not above +30ºC

Local Material: PCD460433CATALENT,CH

Handling Unit ID:

Catalent Order number:

Customer PO number:

Jadenu-shipper-label-360

PRINCIPAL DISPLAY PANEL

PALLET LABEL

Product: Jadenu GRU 90mg ALU (X30) US

Novartis ESO PO:

Batch:

Material Code:

Customer PO:

MFD:

Delivery:

EXP:

SHIPPER:

Catalent Pharma Solutions GmbH

Riedstrabe 1

6330 Cham

Switzerland

Intermediate:

Planzer Transport AG

C/O Crossdocking

Salinenstrabe 63

4133 Pratteln

Switzerland

Consignee:

Shipping Marks:

Local Material: PCD460429CATALENT, CH

Handling Unit ID:

Quantity: 10180 finished packs per pallet

Net weight:

NSC: 9A

Gross Weight:

Tempcontrol: Transport and Intermediate storage not above +30ºC

jadenu-pallet-label-90

PRINCIPAL DISPLAY PANEL

PALLET LABEL

Product: Jadenu GRU 180mg ALU (X30) US

Novartis ESO PO:

Batch:

Material Code: 736127

Customer PO:

MFD:

Delivery:

EXP:

Shipper:

Catalent Pharma Solutions GmbH

Riedstrabe 1

6330 Cham

Switzerland

Intermediate:

Planzer Transport AG

C/O Crossdocking

Salinenstrabe 63

4133 Pratteln

Switzerland

Consignee:

Shipping Marks:

Local Material: PCD46043CATALENT, CH

Handling Unit ID:

Quantity: 180 finished packs per pallet

Net Weight:

NSC: 9A

Gross Weight:

Tempcontrol: Transport and intermediate storage not above +30ºC

Jadenu-pallet-label-180

PRINCIPAL DISPLAY PANEL

PALLET LABEL

Product: Jadenu GRU 360mg ALU (X30) US

Novartis ESO PO:

Batch:

Material Code:

Customer PO:

MFD:

Delivery:

EXP:

Shipper:

Catalent Pharma Solutions, GmbH

Riedstrabe 1

6330 Cham

Switzerland

Intermediate:

Planzer Transport AG

C/O Crossdocking

Salinenstrabe 63

4133 Pratteln

Switzerland

Consignee:

Shipping Marks:

Local Material: PCD460433CATALENT,CH

Handling Unit ID:

Quantity: 1080 finished packs per pallet

Net weight:

Gross weight:

NSC: 9A

Tempcontrol: Transport and intermediate storage not above +30ºC

Jadenu-pallet-label-360