Prescription drug · NDA
Somatuline Depot (lanreotide acetate) NDC 15054-1090
Lanreotide acetate 90 mg/.3mL · Injection · Subcutaneous · Ipsen Biopharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 15054-1090-4 | 15054109004 | 1 POUCH in 1 CARTON (15054-1090-4) / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGEMarketed from Sep 1, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Somatuline Depot
- Generic name (nonproprietary)
- lanreotide acetate
- Active ingredients
- Lanreotide acetate — 90 mg/.3mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022074
- Marketing start
- Listing expires
- Other FDA classes
- Somatostatin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 15054-1090_1cafe88a-b7a2-42ff-bb99-3dd17538c58bSPL ID 1cafe88a-b7a2-42ff-bb99-3dd17538c58bSPL set ID 6e4a41fd-a753-4362-87ee-8cc56ed3660dRxCUI 749811, 749813, 749814, 749816, 749817, 749818UNII IEU56G3J9C
- Pharmacologic class
- Somatostatin Analog
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N415054109004followed by a unit qualifier and the quantityPackage 15054-1090-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. ( 1.2 ) the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. ( 1.3 ) 1.1 Acromegaly SOMATULINE DEPOT is indicated for the long-term treatment of acromegalic patients who have had an inadequate resp…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022074
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Somatuline Depotlanreotide acetate | Lanreotide acetate 60 mg/.2mL | InjectionSubcutaneous | Ipsen Biopharmaceuticals, Inc. | 15054-1060 |
| Somatuline Depotlanreotide acetate | Lanreotide acetate 120 mg/.5mL | InjectionSubcutaneous | Ipsen Biopharmaceuticals, Inc. | 15054-1120 |