somatuline depot

Generic: lanreotide acetate

Labeler: ipsen biopharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name somatuline depot
Generic Name lanreotide acetate
Labeler ipsen biopharmaceuticals, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

lanreotide acetate 120 mg/.5mL

Manufacturer
Ipsen Biopharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 15054-1120
Product ID 15054-1120_1cafe88a-b7a2-42ff-bb99-3dd17538c58b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022074
Listing Expiration 2026-12-31
Marketing Start 2007-11-14

Pharmacologic Class

Classes
somatostatin analog [epc] somatostatin receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 150541120
Hyphenated Format 15054-1120

Supplemental Identifiers

RxCUI
749811 749813 749814 749816 749817 749818
UNII
IEU56G3J9C

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name somatuline depot (source: ndc)
Generic Name lanreotide acetate (source: ndc)
Application Number NDA022074 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 120 mg/.5mL
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (15054-1120-4) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE
source: ndc

Packages (1)

15054-1120-4 1 POUCH in 1 CARTON (15054-1120-4) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE

Ingredients (1)

lanreotide acetate (120 mg/.5mL)

Linked Drug Pages (1)

SOMATULINE DEPOT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "1cafe88a-b7a2-42ff-bb99-3dd17538c58b", "openfda": {"unii": ["IEU56G3J9C"], "rxcui": ["749811", "749813", "749814", "749816", "749817", "749818"], "spl_set_id": ["6e4a41fd-a753-4362-87ee-8cc56ed3660d"], "manufacturer_name": ["Ipsen Biopharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (15054-1120-4)  / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE", "package_ndc": "15054-1120-4", "marketing_start_date": "20190901"}], "brand_name": "SOMATULINE DEPOT", "product_id": "15054-1120_1cafe88a-b7a2-42ff-bb99-3dd17538c58b", "dosage_form": "INJECTION", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "15054-1120", "generic_name": "lanreotide acetate", "labeler_name": "Ipsen Biopharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOMATULINE DEPOT", "active_ingredients": [{"name": "LANREOTIDE ACETATE", "strength": "120 mg/.5mL"}], "application_number": "NDA022074", "marketing_category": "NDA", "marketing_start_date": "20071114", "listing_expiration_date": "20261231"}