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NDC 00078-0109-01 Sandimmune 50 mg/mL Details
Sandimmune 50 mg/mL
Sandimmune is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is CYCLOSPORINE.
MedlinePlus Drug Summary
Cyclosporine injection is used with other medications to prevent transplant rejection (attack of the transplanted organ by the immune system of the person receiving the organ) in people who have received kidney, liver, and heart transplants. Cyclosporine injection should only be used to treat people who are unable to take cyclosporine by mouth. Cyclosporine is in a class of medications called immunosuppressants. It works by decreasing the activity of the immune system.
Related Packages: 00078-0109-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cyclosporine Injection
Product Information
| NDC | 00078-0109 |
|---|---|
| Product ID | 0078-0109_5fd4ecdc-1dd9-4887-8817-d63e871d5c92 |
| Associated GPIs | 99402020002005 |
| GCN Sequence Number | 062197 |
| GCN Sequence Number Description | cyclosporine AMPUL 250 MG/5ML INTRAVEN |
| HIC3 | Z2E |
| HIC3 Description | IMMUNOSUPPRESSIVES |
| GCN | 97981 |
| HICL Sequence Number | 004524 |
| HICL Sequence Number Description | CYCLOSPORINE |
| Brand/Generic | Brand |
| Proprietary Name | Sandimmune |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | cyclosporine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | CYCLOSPORINE |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050573 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00078-0109-01 (00078010901)
| NDC Package Code | 0078-0109-01 |
|---|---|
| Billing NDC | 00078010901 |
| Package | 10 AMPULE in 1 BOX (0078-0109-01) / 5 mL in 1 AMPULE (0078-0109-61) |
| Marketing Start Date | 1983-11-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |