NDC Code(s) : 15054-0060-1, 15054-0090-1, 15054-0120-1
Packager : Ipsen Biopharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Somatuline Depotlanreotide acetate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15054-0060
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lanreotide acetate(UNII: IEU56G3J9C)
(lanreotide - UNII:0G3DE8943Y) 		lanreotide60 mg in 0.2 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:15054-0060-11 in 1 CARTON
11 in 1 POUCH
10.2 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022074 11/14/2007
Somatuline Depotlanreotide acetate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15054-0090
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lanreotide acetate(UNII: IEU56G3J9C)
(lanreotide - UNII:0G3DE8943Y) 		lanreotide90 mg in 0.3 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:15054-0090-11 in 1 CARTON
11 in 1 POUCH
10.3 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022074 11/14/2007
Somatuline Depotlanreotide acetate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15054-0120
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lanreotide acetate(UNII: IEU56G3J9C)
(lanreotide - UNII:0G3DE8943Y) 		lanreotide120 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:15054-0120-11 in 1 CARTON
11 in 1 POUCH
10.5 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022074 11/14/2007

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 60 mg/0.2 ml Syringe Carton

NDC 15054 0060 1

Somatuline ® Depot
(lanreotide) Injection 60 mg/0.2 ml

For deep subcutaneous injection
Rx only. For single use only. Sterile.
Warning: Needle Sheath Contains Dry Natural Rubber

CONTENTS: This box contains one (1) pre-filled syringe. Each syringe contains lanreotide acetate corresponding to
60 mg of lanreotide base per 0.2 ml solution, which is the equivalent of 60 mg lanreotide per syringe.

60 mg

IPSEN

PRINCIPAL DISPLAY PANEL - 60 mg/0.2 ml Syringe Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 90 mg/0.3 ml Syringe Carton

NDC 15054 0090 1

Somatuline ® Depot
(lanreotide) Injection 90 mg/0.3 ml

For deep subcutaneous injection
Rx only. For single use only. Sterile.
Warning: Needle Sheath Contains Dry Natural Rubber

CONTENTS: This box contains one (1) pre-filled syringe. Each syringe contains lanreotide acetate corresponding to
90 mg of lanreotide base per 0.3 ml solution, which is the equivalent of 90 mg lanreotide per syringe.

90 mg

IPSEN

PRINCIPAL DISPLAY PANEL - 90 mg/0.3 ml Syringe Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 120 mg/0.5 ml Syringe Carton

NDC 15054 0120 1

Somatuline ® Depot
(lanreotide) Injection 120 mg/0.5 ml

For deep subcutaneous injection
Rx only. For single use only. Sterile.
Warning: Needle Sheath Contains Dry Natural Rubber

CONTENTS: This box contains one (1) pre-filled syringe. Each syringe contains lanreotide acetate corresponding to
120 mg of lanreotide base per 0.5 ml solution, which is the equivalent of 120 mg lanreotide per syringe.

120 mg

IPSEN

PRINCIPAL DISPLAY PANEL - 120 mg/0.5 ml Syringe Carton