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NDC 00078-0393-61 Simulect 10 mg/2.5mL Details
Simulect 10 mg/2.5mL
Simulect is a INTRAVENOUS INJECTION, POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is BASILIXIMAB.
MedlinePlus Drug Summary
Basiliximab injection is used with other medications to prevent immediate transplant rejection (attack of the transplanted organ by the immune system of the person receiving the organ) in people who are receiving kidney transplants. Basiliximab injection is in a class of medications called immunosuppressants. It works by decreasing the activity of the body's immune system so it will not attack the transplanted organ.
Related Packages: 00078-0393-61Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Basiliximab Injection
Product Information
| NDC | 00078-0393 |
|---|---|
| Product ID | 0078-0393_d25af03e-66f5-4184-a769-cbe62de929f9 |
| Associated GPIs | 99405015002110 |
| GCN Sequence Number | 051824 |
| GCN Sequence Number Description | basiliximab VIAL 10 MG INTRAVEN |
| HIC3 | Z2M |
| HIC3 Description | IMMUNOSUPP - MONOCLONAL AB INHIBITING T LYMPH FXN |
| GCN | 19217 |
| HICL Sequence Number | 018390 |
| HICL Sequence Number Description | BASILIXIMAB |
| Brand/Generic | Brand |
| Proprietary Name | Simulect |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | basiliximab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/2.5mL |
| Substance Name | BASILIXIMAB |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA103764 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0393-61 (00078039361)
| NDC Package Code | 0078-0393-61 |
|---|---|
| Billing NDC | 00078039361 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (0078-0393-61) / 2.5 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 1998-05-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |