FDA.reportPublic FDA data

SOMATULINE DEPOT

Product NDC
15054-1120
11-digit product format
150541120
Labeler code
15054
Product ID
15054-1120_1cafe88a-b7a2-42ff-bb99-3dd17538c58b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lanreotide acetate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Ipsen Biopharmaceuticals, Inc.
Application
NDA022074
Marketing category
NDA
Marketing start
2007-11-14
Substance
LANREOTIDE ACETATE
Active strength
120 mg/.5mL
Pharmacologic classes
Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SOMATULINE DEPOT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANREOTIDE ACETATE120 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIEU56G3J9C
Rxcui749811, 749813, 749814, 749816, 749817, 749818

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3340e9ad-5e0e-4ddc-aa91-4357df39a30fProduct name220250221
e9869da2-9f36-4263-93de-4156429775d7Product name120220720
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15054-1120-4SOMATULINE DEPOT1 in 1 POUCHINJECTION116
15054-1120-4SOMATULINE DEPOT1 in 1 CARTONINJECTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15054-1120-3ML - Milliliter15054-112034e89aa9-1497-4bfd-9cc5-fe2dee082c6312015-01-05
15054-1120-4ML - Milliliter15054-112091991cf6-a6e1-4f2e-91de-aa1ea530bae212019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lanreotide acetateACTIVE INGREDIENTIEU56G3J9CSOMATULINE DEPOT (LANREOTIDE ACETATE) INJECTION [IPSEN BIOPHARMACEUTICALS, INC.]2
lanreotideACTIVE MOIETY0G3DE8943YSOMATULINE DEPOT (LANREOTIDE ACETATE) INJECTION [IPSEN BIOPHARMACEUTICALS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RSOMATULINE DEPOT (LANREOTIDE ACETATE) INJECTION [IPSEN BIOPHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15054-1120SOMATULINE DEPOT (LANREOTIDE ACETATE) INJECTION [IPSEN BIOPHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 2 package rows20241017_6e4a41fd-a753-4362-87ee-8cc56ed3660d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749814lanreotide 120 MG in 0.5 ML Prefilled SyringePSN6e4a41fd-a753-4362-87ee-8cc56ed3660d16
749811lanreotide 60 MG in 0.2 ML Prefilled SyringePSN6e4a41fd-a753-4362-87ee-8cc56ed3660d16
749817lanreotide 90 MG in 0.3 ML Prefilled SyringePSN6e4a41fd-a753-4362-87ee-8cc56ed3660d16
749816Somatuline Depot 120 MG in 0.5 ML Prefilled SyringePSN6e4a41fd-a753-4362-87ee-8cc56ed3660d16
749813Somatuline Depot 60 MG in 0.2 ML Prefilled SyringePSN6e4a41fd-a753-4362-87ee-8cc56ed3660d16
749818Somatuline Depot 90 MG in 0.3 ML Prefilled SyringePSN6e4a41fd-a753-4362-87ee-8cc56ed3660d16
7498130.2 ML lanreotide 300 MG/ML Prefilled Syringe [Somatuline]SBD6e4a41fd-a753-4362-87ee-8cc56ed3660d16
7498180.3 ML lanreotide 300 MG/ML Prefilled Syringe [Somatuline]SBD6e4a41fd-a753-4362-87ee-8cc56ed3660d16
7498160.5 ML lanreotide 240 MG/ML Prefilled Syringe [Somatuline]SBD6e4a41fd-a753-4362-87ee-8cc56ed3660d16
7498110.2 ML lanreotide 300 MG/ML Prefilled SyringeSCD6e4a41fd-a753-4362-87ee-8cc56ed3660d16
7498170.3 ML lanreotide 300 MG/ML Prefilled SyringeSCD6e4a41fd-a753-4362-87ee-8cc56ed3660d16
7498140.5 ML lanreotide 240 MG/ML Prefilled SyringeSCD6e4a41fd-a753-4362-87ee-8cc56ed3660d16
7498130.2 ML Somatuline 300 MG/ML (as lanreotide acetate) Prefilled SyringeSY6e4a41fd-a753-4362-87ee-8cc56ed3660d16
7498130.2 ML Somatuline 300 MG/ML Prefilled SyringeSY6e4a41fd-a753-4362-87ee-8cc56ed3660d16
7498180.3 ML Somatuline 300 MG/ML (as lanreotide acetate) Prefilled SyringeSY6e4a41fd-a753-4362-87ee-8cc56ed3660d16
7498180.3 ML Somatuline 300 MG/ML Prefilled SyringeSY6e4a41fd-a753-4362-87ee-8cc56ed3660d16
7498160.5 ML lanreotide 240 MG/ML ( as lanreotide acetate) Prefilled Syringe [Somatuline]SY6e4a41fd-a753-4362-87ee-8cc56ed3660d16
7498140.5 ML lanreotide 240 MG/ML (as lanreotide acetate) Prefilled SyringeSY6e4a41fd-a753-4362-87ee-8cc56ed3660d16
749814lanreotide 120 MG per 0.5 ML Prefilled SyringeSY6e4a41fd-a753-4362-87ee-8cc56ed3660d16
749811lanreotide 60 MG per 0.2 ML (as lanreotide acetate) Prefilled SyringeSY6e4a41fd-a753-4362-87ee-8cc56ed3660d16
749817lanreotide 90 MG per 0.3 ML (as lanreotide acetate) Prefilled SyringeSY6e4a41fd-a753-4362-87ee-8cc56ed3660d16
749816Somatuline Depot 120 MG per 0.5 ML Prefilled SyringeSY6e4a41fd-a753-4362-87ee-8cc56ed3660d16
749813Somatuline Depot 60 MG per 0.2 ML Prefilled SyringeSY6e4a41fd-a753-4362-87ee-8cc56ed3660d16
749818Somatuline Depot 90 MG per 0.3 ML Prefilled SyringeSY6e4a41fd-a753-4362-87ee-8cc56ed3660d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15054-1120-3150541120031 POUCH in 1 CARTON (15054-1120-3) > 1 SYRINGE in 1 POUCH > .5 mL in 1 SYRINGE1 pouch2007-11-142022-06-30NoNoCurrent
15054-1120-4150541120041 POUCH in 1 CARTON (15054-1120-4) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE1 pouch2019-09-010000-00-00NoNoCurrent