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NDC 00024-0656-01 Sarclisa 500 mg/25mL Details
Sarclisa 500 mg/25mL
Sarclisa is a INTRAVENOUS INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by sanof-aventis U.S. LLC. The primary component is ISATUXIMAB.
MedlinePlus Drug Summary
Isatuximab-irfc injection is used along with pomalidomide (Pomalyst) and dexamethasone to treat multiple myeloma (a type of cancer of the bone marrow) in adults who have received at least two other medications, including lenalidomide (Revlimid) and a proteasome inhibitor such as bortezomib (Velcade) or carfilzomib (Kyprolis). It is also used along with carfilzomib (Kyprolis) and dexamethasone to treat multiple myeloma in adults whose cancer has returned or is unresponsive to at least one other treatment. Isatuximab-irfc injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.
Related Packages: 00024-0656-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Isatuximab-irfc Injection
Product Information
| NDC | 00024-0656 |
|---|---|
| Product ID | 0024-0656_fb20a1b6-f85c-4ab8-9f68-eb5f27ffd781 |
| Associated GPIs | 21354033202030 |
| GCN Sequence Number | 080796 |
| GCN Sequence Number Description | isatuximab-irfc VIAL 500MG/25ML INTRAVEN |
| HIC3 | V3V |
| HIC3 Description | ANTINEOPLASTIC - ANTI-CD38 MONOCLONAL ANTIBODY |
| GCN | 47773 |
| HICL Sequence Number | 046389 |
| HICL Sequence Number Description | ISATUXIMAB-IRFC |
| Brand/Generic | Brand |
| Proprietary Name | Sarclisa |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | isatuximab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/25mL |
| Substance Name | ISATUXIMAB |
| Labeler Name | sanof-aventis U.S. LLC |
| Pharmaceutical Class | Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761113 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00024-0656-01 (00024065601)
| NDC Package Code | 0024-0656-01 |
|---|---|
| Billing NDC | 00024065601 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (0024-0656-01) / 25 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2020-03-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |