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NDC 66658-0525-01 GAMIFANT 500 mg/20mL Details
GAMIFANT 500 mg/20mL
GAMIFANT is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Swedish Orphan Biovitrum AB (publ). The primary component is EMAPALUMAB.
MedlinePlus Drug Summary
Emapalumab-lzsg injection is used to treat adults and children (newborn and older) with primary hemophagocytic lymphohistiocytosis (HLH; an inherited condition in which the immune system does not work normally and causes swelling and damage to the liver, brain, and bone marrow) whose disease has not improved, has gotten worse, or has come back after previous treatment or who are unable to take other medications. Emapalumab-lzsg injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain protein in the immune system that causes inflammation.
Related Packages: 66658-0525-01Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Emapalumab-lzsg Injection
Product Information
| NDC | 66658-0525 |
|---|---|
| Product ID | 66658-525_924766fc-c878-4a8e-b1f5-3fc40136be17 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | GAMIFANT |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | emapalumab-lzsg |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/20mL |
| Substance Name | EMAPALUMAB |
| Labeler Name | Swedish Orphan Biovitrum AB (publ) |
| Pharmaceutical Class | Interferon gamma Antagonists [MoA], Interferon gamma Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761107 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 66658-0525-01 (66658052501)
| NDC Package Code | 66658-525-01 |
|---|---|
| Billing NDC | 66658052501 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (66658-525-01) / 20 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2023-06-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |