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NDC 15054-1120-04 SOMATULINE DEPOT 120 mg/.5mL Details
SOMATULINE DEPOT 120 mg/.5mL
SOMATULINE DEPOT is a SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ipsen Biopharmaceuticals, Inc.. The primary component is LANREOTIDE ACETATE.
MedlinePlus Drug Summary
Lanreotide injection is used to treat people with acromegaly (condition in which the body produces too much growth hormone, causing enlargement of the hands, feet, and facial features; joint pain; and other symptoms) who have not successfully, or cannot be treated with surgery or radiation. Lanreotide injection is also used to treat people with neuroendocrine tumors in the gastrointestinal (GI) tract or the pancreas (GEP-NETs) that have spread or cannot be removed by surgery. Lanreotide injection is in a class of medications called somatostatin agonists. It works by decreasing the amounts of certain natural substances produced by the body.
Related Packages: 15054-1120-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Lanreotide Injection
Product Information
| NDC | 15054-1120 |
|---|---|
| Product ID | 15054-1120_3cbf9cb7-cf01-4062-9e57-43e0f1c267a1 |
| Associated GPIs | 30170050102040 |
| GCN Sequence Number | 049572 |
| GCN Sequence Number Description | lanreotide acetate SYRINGE 120MG/0.5 SUBCUT |
| HIC3 | P1B |
| HIC3 Description | SOMATOSTATIC AGENTS |
| GCN | 15132 |
| HICL Sequence Number | 010781 |
| HICL Sequence Number Description | LANREOTIDE ACETATE |
| Brand/Generic | Brand |
| Proprietary Name | SOMATULINE DEPOT |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | lanreotide acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 120 |
| Active Ingredient Units | mg/.5mL |
| Substance Name | LANREOTIDE ACETATE |
| Labeler Name | Ipsen Biopharmaceuticals, Inc. |
| Pharmaceutical Class | Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022074 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 15054-1120-04 (15054112004)
| NDC Package Code | 15054-1120-4 |
|---|---|
| Billing NDC | 15054112004 |
| Package | 1 POUCH in 1 CARTON (15054-1120-4) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE |
| Marketing Start Date | 2019-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |