Saizen (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 5 mg Kit Carton

saizen® 5 mg
(somatropin) for injection

NDC 44087-1005-2

5 mg
For subcutaneous injection
Rx Only

1 vial SAIZEN
1 vial Bacteriostatic Water for
Injection, USP (0.9% Benzyl Alcohol)

EMD SERONO

PRINCIPAL DISPLAY PANEL -- 5 mg Kit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 8.8 mg Kit Carton

saizen® 8.8 mg
(somatropin) for injection

NDC 44087-1088-1

8.8 mg
For subcutaneous injection
Rx Only

1 vial SAIZEN
1 vial Bacteriostatic Water for
Injection, USP (0.9% Benzyl Alcohol)

EMD SERONO

PRINCIPAL DISPLAY PANEL -- 8.8 mg Kit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 8.8 mg Reconstitution Kit Carton

NDC 44087-0016-1

saizen® 8.8 mg

(somatropin) for injection 5.83 mg/mL

Reconstitution Kit

Approximately 5.83 mg/mL of the drug is delivered
For subcutaneous injection
Exclusively for use with designated Saizen® delivery devices

Rx only

1
vial Saizen® 8.8 mg
1
cartridge of diluent
1
saizenprep® Reconstitution Device

EMD SERONO

PRINCIPAL DISPLAY PANEL -- 8.8 mg Reconstitution Kit Carton
(click image for full-size original)
SAIZEN somatropin kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44087-1005
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44087-1005-2 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 3 mL
Part 2 1 VIAL, GLASS 3.5 mL
Part 1 of 2
SAIZEN somatropin injection, powder, lyophilized, for solution
Product Information
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOMATROPIN (SOMATROPIN) SOMATROPIN 5 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE 34.2 mg in 3 mL
PHOSPHORIC ACID 1.16 mg in 3 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 3 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA019764 10/08/1996
Part 2 of 2
BACTERIOSTATIC WATER bacteriostatic water injection
Product Information
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 3.5 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA019764 10/08/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA019764 10/08/1996 10/31/2024
SAIZEN somatropin kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44087-1088
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44087-1088-1 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 3 mL
Part 2 1 VIAL, GLASS 3.5 mL
Part 1 of 2
SAIZEN somatropin injection, powder, lyophilized, for solution
Product Information
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOMATROPIN (SOMATROPIN) SOMATROPIN 8.8 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE 60.2 mg in 3 mL
PHOSPHORIC ACID 2.05 mg in 3 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 3 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA019764 10/08/1996
Part 2 of 2
BACTERIOSTATIC WATER bacteriostatic water injection
Product Information
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 3.5 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA019764 10/08/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA019764 08/29/2000 03/31/2024
SAIZENPREP somatropin kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44087-0016
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44087-0016-1 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 1.51 mL
Part 2 1 CARTRIDGE 1.51 mL
Part 1 of 2
SAIZENPREP somatropin injection, powder, lyophilized, for solution
Product Information
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOMATROPIN (SOMATROPIN) SOMATROPIN 8.8 mg in 1.51 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE 60.2 mg in 1.51 mL
PHOSPHORIC ACID 2.05 mg in 1.51 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 1.51 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA019764 10/08/1996
Part 2 of 2
STERILE WATER sterile water injection
Product Information
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER
METACRESOL
Packaging
# Item Code Package Description Multilevel Packaging
1 1.51 mL in 1 CARTRIDGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA019764 10/08/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA019764 01/17/2017 05/31/2023
Labeler — EMD Serono, Inc. (088514898)

Revised: 06/2023 EMD Serono, Inc.

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