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NDC 00078-0110-22 Sandimmune 100 mg/mL Details
Sandimmune 100 mg/mL
Sandimmune is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is CYCLOSPORINE.
MedlinePlus Drug Summary
Cyclosporine and cyclosporine (modified) are used with other medications to prevent transplant rejection (attack of the transplanted organ by the immune system of the person who received the organ) in people who have received kidney, liver, and heart transplants. Cyclosporine (modified) is also used alone or with methotrexate (Rheumatrex) to treat the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints) in patients whose symptoms were not relieved by methotrexate alone. Cyclosporine (modified) is also used to treat psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in certain patients who have not been helped by other treatments. Cyclosporine and cyclosporine (modified) are in a class of medications called immunosuppressants. They work by decreasing the activity of the immune system.
Related Packages: 00078-0110-22Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cyclosporine
Product Information
| NDC | 00078-0110 |
|---|---|
| Product ID | 0078-0110_5fd4ecdc-1dd9-4887-8817-d63e871d5c92 |
| Associated GPIs | 99402020002010 |
| GCN Sequence Number | 011684 |
| GCN Sequence Number Description | cyclosporine SOLUTION 100 MG/ML ORAL |
| HIC3 | Z2E |
| HIC3 Description | IMMUNOSUPPRESSIVES |
| GCN | 08220 |
| 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 | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| 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 | NDA050574 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00078-0110-22 (00078011022)
| NDC Package Code | 0078-0110-22 |
|---|---|
| Billing NDC | 00078011022 |
| Package | 50 mL in 1 BOTTLE (0078-0110-22) |
| Marketing Start Date | 1983-11-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |