Somatuline Depot (lanreotide acetate) NDC 15054-1120

NDC codes

FDA NDC Directory

Product NDC (as listed)15054-1120Labeler and product segments. Claims need a package NDC.

Product NDC at billing width15054-1120Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
15054-1120-4	15054112004	1 POUCH in 1 CARTON (15054-1120-4) / 1 SYRINGE in 1 POUCH / .5 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 — 120 mg/.5mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Ipsen Biopharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022074
Marketing start: Nov 14, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Somatostatin Receptor Agonists (Mechanism)
Identifiers: Product ID 15054-1120_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.

How CPT relates to drug billing

NDC on a medical claim

N415054112004 followed by a unit qualifier and the quantity

Package 15054-1120-04. 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 Oct 11, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022074

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022074
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 90 mg/.3mL	InjectionSubcutaneous	Ipsen Biopharmaceuticals, Inc.	15054-1090