Prescription drug · NDA
Sandostatin LAR Depot (Octreotide acetate) NDC 0078-0818
Kit · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0818-81 | 00078081881 | 1 KIT in 1 KIT (0078-0818-81) * 6 mL in 1 VIAL (0078-0797-61) * 2 mL in 1 SYRINGEMarketed from Jul 22, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Sandostatin LAR Depot
- Generic name (nonproprietary)
- octreotide acetate
- Dosage form
- Kit
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021008
- Marketing start
- Listing expires
- Identifiers
- Product ID 0078-0818_2a2ad59f-21cd-4734-9c4b-0154e9db1642SPL ID 2a2ad59f-21cd-4734-9c4b-0154e9db1642SPL set ID d0b7fe9e-7000-4b79-ba3b-291ce92c14f9RxCUI 898589, 898591, 898601, 898603, 898605, 898607
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.
- NDC on a medical claim
N400078081881followed by a unit qualifier and the quantityPackage 00078-0818-81. 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)
SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated. SANDOSTATIN LAR DEPOT is a somatostatin analogue indicated for: Treatment in patients who have responded to and tolerated Sandostatin Injection subcutaneous injection for: Acromegaly ( 1.1 ) Severe diarrhea/flushing episodes associated with metastatic carcinoid tumors ( 1.2 ) Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors ( 1.3 ) 1.1 Acromegaly Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom sur…
Excerpt only. Read the full label for complete information.
About NDC 0078-0818
- What is NDC 0078-0818?
- 0078-0818 is the product NDC for Sandostatin LAR Depot (octreotide acetate) kit, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sandostatin LAR Depot (Octreotide acetate).
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sandostatin LAR Depot?
- 2 other product NDCs are listed under this name. See all Sandostatin LAR Depot NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sandostatin LAR Depot products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sandostatin LAR Depotoctreotide acetate | — | Kit | Novartis Pharmaceuticals Corporation | 0078-0811 | 00078-0811-81 |
| Sandostatin LAR Depotoctreotide acetate | — | Kit | Novartis Pharmaceuticals Corporation | 0078-0825 | 00078-0825-81 |
Other NDCs under NDA 021008
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 |
|---|---|---|---|---|
| Sandostatin LAR Depotoctreotide acetate | — | Kit | Novartis Pharmaceuticals Corporation | 0078-0811 |
| Sandostatin LAR Depotoctreotide acetate | — | Kit | Novartis Pharmaceuticals Corporation | 0078-0825 |