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NDC 00003-2291-11 EMPLICITI 300 mg/1 Details
EMPLICITI 300 mg/1
EMPLICITI is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by E.R. Squibb & Sons, L.L.C.. The primary component is ELOTUZUMAB.
MedlinePlus Drug Summary
Elotuzumab injection is used along with lenalidomide (Revlimid) and dexamethasone or along with pomalidomide (Pomalyst) and dexamethasone to treat multiple myeloma (a type of cancer of the bone marrow) that has not improved with treatment or that had improved after treatment with other medications but later returned. Elotuzumab 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: 00003-2291-11Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Elotuzumab Injection
Product Information
| NDC | 00003-2291 |
|---|---|
| Product ID | 0003-2291_ef47282a-3cff-40ed-867f-36af14c8f99c |
| Associated GPIs | 21359030002120 |
| GCN Sequence Number | 075215 |
| GCN Sequence Number Description | elotuzumab VIAL 300 MG INTRAVEN |
| HIC3 | V3W |
| HIC3 Description | ANTINEOPLASTIC - ANTI-SLAMF7 MONOCLONAL ANTIBODY |
| GCN | 40227 |
| HICL Sequence Number | 042842 |
| HICL Sequence Number Description | ELOTUZUMAB |
| Brand/Generic | Brand |
| Proprietary Name | EMPLICITI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | elotuzumab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/1 |
| Substance Name | ELOTUZUMAB |
| Labeler Name | E.R. Squibb & Sons, L.L.C. |
| Pharmaceutical Class | Antibodies, Monoclonal [CS], SLAMF7-directed Antibody Interactions [MoA], SLAMF7-directed Immunostimulatory Antibody [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761035 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00003-2291-11 (00003229111)
| NDC Package Code | 0003-2291-11 |
|---|---|
| Billing NDC | 00003229111 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (0003-2291-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2015-11-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |