Prescription drug · NDA
Sandostatin (octreotide acetate) NDC 0078-0181
Octreotide acetate 100 ug/mL · Injection, Solution · Intravenous, Subcutaneous · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0181-01 | 00078018101 | 10 AMPULE in 1 PACKAGE (0078-0181-01) / 1 mL in 1 AMPULE (0078-0181-61)Marketed from Oct 21, 1988 |
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
- Generic name (nonproprietary)
- octreotide acetate
- Active ingredients
- Octreotide acetate — 100 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019667
- Marketing start
- Listing expires
- Other FDA classes
- Somatostatin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0078-0181_3f1a424d-05a3-40d6-8127-44948e411611SPL ID 3f1a424d-05a3-40d6-8127-44948e411611SPL set ID 4e2c9856-1836-49f0-9472-4dbeeb408f39RxCUI 207194, 207198, 207200, 312068, 312069, 312070UNII 75R0U2568I
- 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
N400078018101followed by a unit qualifier and the quantityPackage 00078-0181-01. 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 Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. ( 1.1 ) Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. ( 1.2 ) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 019667
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 |
|---|---|---|---|---|
| Sandostatinoctreotide acetate | Octreotide acetate 500 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Novartis Pharmaceuticals Corporation | 0078-0182 |
| Sandostatinoctreotide acetate | Octreotide acetate 50 ug/mL | Injection, SolutionIntravenous, Subcutaneous | Novartis Pharmaceuticals Corporation | 0078-0180 |