SOMATULINE DEPOT
These highlights do not include all the information needed to use SOMATULINE DEPOT safely and effectively. See full prescribing information for SOMATULINE DEPOT. SOMATULINE DEPOT (lanreotide) injection, for subcutaneous use Initial U.S. Approval: 2007
Approved
Approval ID
6e4a41fd-a753-4362-87ee-8cc56ed3660d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2023
Manufacturers
FDA
Ipsen Biopharmaceuticals, Inc.
DUNS: 118461578
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lanreotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15054-1060
Application NumberNDA022074
Product Classification
M
Marketing Category
C73594
G
Generic Name
lanreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (3)
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Acetic AcidInactive
Code: Q40Q9N063P
Classification: IACT
lanreotide acetateActive
Quantity: 60 mg in 0.2 mL
Code: IEU56G3J9C
Classification: ACTIM
lanreotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15054-1090
Application NumberNDA022074
Product Classification
M
Marketing Category
C73594
G
Generic Name
lanreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (3)
WaterInactive
Code: 059QF0KO0R
Classification: IACT
lanreotide acetateActive
Quantity: 90 mg in 0.3 mL
Code: IEU56G3J9C
Classification: ACTIM
Acetic AcidInactive
Code: Q40Q9N063P
Classification: IACT
lanreotide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15054-1120
Application NumberNDA022074
Product Classification
M
Marketing Category
C73594
G
Generic Name
lanreotide acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (3)
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Acetic AcidInactive
Code: Q40Q9N063P
Classification: IACT
lanreotide acetateActive
Quantity: 120 mg in 0.5 mL
Code: IEU56G3J9C
Classification: ACTIM