Prescription drug · NDA
Sandimmune (Cyclosporine) NDC 0078-0109
Cyclosporine 50 mg/mL · Injection · Intravenous · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0109-01 | 00078010901 | 10 AMPULE in 1 BOX (0078-0109-01) / 5 mL in 1 AMPULE (0078-0109-61)Marketed from Nov 14, 1983 |
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)
- Sandimmune
- Generic name (nonproprietary)
- cyclosporine
- Active ingredients
- Cyclosporine — 50 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050573
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0078-0109_e56d1b6b-27a1-48a9-9f4e-de0c5ba08690SPL ID e56d1b6b-27a1-48a9-9f4e-de0c5ba08690SPL set ID 5e5926a7-1de0-4b54-a5c0-286b6200ff82RxCUI 197552, 197553, 205175, 212810, 212844, 328160UNII 83HN0GTJ6D
- Pharmacologic class
- Calcineurin Inhibitor Immunosuppressant
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
N400078010901followed by a unit qualifier and the quantityPackage 00078-0109-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Sandimmune capsules and Sandimmune injection, in combination with adrenal corticosteroids, are indicated for the: Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Because of the risk of anaphylaxis, Sandimmune injection should be reserved for patients who are unable to take the Sandimmune capsules.
Excerpt only. Read the full label for complete information.
About NDC 0078-0109
- What is NDC 0078-0109?
- 0078-0109 is the product NDC for Sandimmune (cyclosporine), Cyclosporine 50 mg/mL injection, 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?
- Sandimmune (Cyclosporine).
- What is the active ingredient?
- Cyclosporine.
- 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 Sandimmune?
- 2 other product NDCs are listed under this name. See all Sandimmune NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sandimmune products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sandimmunecyclosporine | Cyclosporine 25 mg/1 | Capsule, Liquid filledOral | Novartis Pharmaceuticals Corporation | 0078-0240 | 00078-0240-15 |
| Sandimmunecyclosporine | Cyclosporine 100 mg/1 | Capsule, Liquid filledOral | Novartis Pharmaceuticals Corporation | 0078-0241 | 00078-0241-15 |