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NDC 25682-0025-01 Ultomiris 300 mg/3mL Details
Ultomiris 300 mg/3mL
Ultomiris is a INTRAVENOUS SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alexion Pharmaceuticals Inc.. The primary component is RAVULIZUMAB.
MedlinePlus Drug Summary
Ravulizumab-cwvz injection is used in adults and children 1 month of age and older to treat paroxysmal nocturnal hemoglobinuria (PNH: a type of anemia in which too many red blood cells are broken down in the body, so there are not enough healthy cells to bring oxygen to all parts of the body). Ravulizumab-cwvz injection is also used in adults and children 1 month of age and older to treat atypical hemolytic uremic syndrome (aHUS; an inherited condition in which small blood clots form in the body and may cause damage to the blood vessels, blood cells, kidneys, and other parts of the body). Ravulizumab-cwvz injection is also used in adults to treat a certain form of myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness). Ravulizumab-cwvz is in a class of medications called monoclonal antibodies. It works by blocking the activity of the part of the immune system that may damage blood cells in people with PNH and that causes clots to form in people with aHUS. It works by disrupting communication between nerves and muscles in people with MG.
Related Packages: 25682-0025-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ravulizumab-cwvz Injection
Product Information
| NDC | 25682-0025 |
|---|---|
| Product ID | 25682-025_c8439051-24bd-414a-8bd7-26d307991212 |
| Associated GPIs | 85800080202045 |
| GCN Sequence Number | 081587 |
| GCN Sequence Number Description | ravulizumab-cwvz VIAL 300 MG/3ML INTRAVEN |
| HIC3 | M0L |
| HIC3 Description | COMPLEMENT INHIBITORS |
| GCN | 48749 |
| HICL Sequence Number | 045548 |
| HICL Sequence Number Description | RAVULIZUMAB-CWVZ |
| Brand/Generic | Brand |
| Proprietary Name | Ultomiris |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ravulizumab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION, CONCENTRATE |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/3mL |
| Substance Name | RAVULIZUMAB |
| Labeler Name | Alexion Pharmaceuticals Inc. |
| Pharmaceutical Class | Complement Inhibitor [EPC], Complement Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761108 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 25682-0025-01 (25682002501)
| NDC Package Code | 25682-025-01 |
|---|---|
| Billing NDC | 25682002501 |
| Package | 1 VIAL, GLASS in 1 CARTON (25682-025-01) / 3 mL in 1 VIAL, GLASS |
| Marketing Start Date | 2020-10-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |