Prescription drug · NDA
Lanreotide Acetate NDC 69097-870
Lanreotide acetate 120 mg/.5mL · Injection · Subcutaneous · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-870-67 | 6909708706769097087067 | 1 SYRINGE in 1 CARTON (69097-870-67) / .5 mL in 1 SYRINGEMarketed from Dec 24, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Lanreotide Acetate
- Generic name (nonproprietary)
- lanreotide acetate
- Active ingredients
- Lanreotide acetate — 120 mg/.5mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215395
- Marketing start
- Listing expires
- Other FDA classes
- Somatostatin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69097-870_fd205110-15eb-4707-82b2-185e5bbf616bSPL ID fd205110-15eb-4707-82b2-185e5bbf616bSPL set ID 11da176a-99bc-4ada-8b3f-6bd2b37a6313RxCUI 749811, 749814, 749817UNII 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
N469097087067followed by a unit qualifier and the quantityPackage 69097-0870-67. 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)
Lanreotide Injection 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 Lanreotide Injection is indicated for the long-term treatment of acromegalic patients who have had an inadeq…
Excerpt only. Read the full label for complete information.
About NDC 69097-870
- What is NDC 69097-870?
- 69097-870 is the product NDC for Lanreotide Acetate, Lanreotide acetate 120 mg/.5mL injection, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lanreotide Acetate.
- What is the active ingredient?
- Lanreotide acetate.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lanreotide Acetate?
- 9 other product NDCs are listed under this name. See all Lanreotide Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lanreotide Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lanreotide Acetate | Lanreotide acetate 120 mg/.5mL | InjectionSubcutaneous | Amneal Pharmaceuticals LLC | 70121-2517 | 70121-2517-05 |
| Lanreotide Acetate | Lanreotide acetate 120 mg/.5mL | InjectionSubcutaneous | Cipla USA Inc. | 69097-906 | 69097-0906-67 |
| Lanreotide Acetate | Lanreotide acetate 60 mg/.2mL | InjectionSubcutaneous | Cipla USA Inc. | 69097-907 | 69097-0907-67 |
| Lanreotide Acetate | Lanreotide acetate 90 mg/.3mL | InjectionSubcutaneous | Cipla USA Inc. | 69097-908 | 69097-0908-67 |
| Lanreotide Acetate | Lanreotide acetate 60 mg/.2mL | InjectionSubcutaneous | EXELAN PHARMACEUTICALS, INC. | 76282-718 | 76282-0718-67 |
| Lanreotide Acetate | Lanreotide acetate 90 mg/.3mL | InjectionSubcutaneous | EXELAN PHARMACEUTICALS, INC. | 76282-719 | 76282-0719-67 |
| Lanreotide Acetate | Lanreotide acetate 120 mg/.5mL | InjectionSubcutaneous | EXELAN PHARMACEUTICALS, INC. | 76282-720 | 76282-0720-67 |
| Lanreotide Acetate | Lanreotide acetate 60 mg/.2mL | InjectionSubcutaneous | Cipla USA Inc. | 69097-880 | 69097-0880-67 |
| Lanreotide Acetate | Lanreotide acetate 90 mg/.3mL | InjectionSubcutaneous | Cipla USA Inc. | 69097-890 | 69097-0890-67 |
Other NDCs under NDA 215395
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 |
|---|---|---|---|---|
| Lanreotide Acetate | Lanreotide acetate 60 mg/.2mL | InjectionSubcutaneous | Cipla USA Inc. | 69097-880 |
| Lanreotide Acetate | Lanreotide acetate 90 mg/.3mL | InjectionSubcutaneous | Cipla USA Inc. | 69097-890 |