Jadenu (Page 8 of 8)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)
JADENU deferasirox 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 (DEFERASIROX) DEFERASIROX 90 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE K30
MAGNESIUM STEARATE
SILICON DIOXIDE
POLOXAMER 188
Product Characteristics
Color white (White to almost white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68621-0027-1 30 PACKET in 1 CARTON contains a PACKET
1 1 GRANULE in 1 PACKET This package is contained within the CARTON (68621-0027-1)
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
JADENU deferasirox 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 (DEFERASIROX) DEFERASIROX 180 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE K30
MAGNESIUM STEARATE
SILICON DIOXIDE
POLOXAMER 188
Product Characteristics
Color white (White to almost white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68621-0028-1 30 PACKET in 1 CARTON contains a PACKET
1 1 GRANULE in 1 PACKET This package is contained within the CARTON (68621-0028-1)
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
JADENU deferasirox 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 (DEFERASIROX) DEFERASIROX 360 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE K30
MAGNESIUM STEARATE
SILICON DIOXIDE
POLOXAMER 188
Product Characteristics
Color white (White to almost white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68621-0029-1 30 PACKET in 1 CARTON contains a PACKET
1 1 GRANULE in 1 PACKET This package is contained within the CARTON (68621-0029-1)
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
Labeler — Catalent Germany Schorndorf GmbH (315732628)
Establishment
Name Address ID/FEI Operations
Catalent Germany Schorndorf GmbH 315732628 manufacture (68621-0027), pack (68621-0027), label (68621-0027), manufacture (68621-0028), pack (68621-0028), label (68621-0028), manufacture (68621-0029), pack (68621-0029), label (68621-0029)

Revised: 01/2018 Catalent Germany Schorndorf GmbH

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