Prescription drug · BLA
Ultomiris (ravulizumab) NDC 25682-022
Ravulizumab 300 mg/30mL · Solution, Concentrate · Intravenous · Alexion Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25682-022-01 | 25682002201 | 1 VIAL, GLASS in 1 CARTON (25682-022-01) / 30 mL in 1 VIAL, GLASSMarketed from Dec 21, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ultomiris
- Generic name (nonproprietary)
- ravulizumab
- Active ingredients
- Ravulizumab — 300 mg/30mL
- Dosage form
- Solution, Concentrate
- Route
- Intravenous
- Labeler
- Alexion Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761108
- Marketing start
- Listing expires
- Other FDA classes
- Complement Inhibitors (Mechanism)
- Identifiers
- Product ID 25682-022_41262953-a849-4095-b9c2-5a1d8b0238ccSPL ID 41262953-a849-4095-b9c2-5a1d8b0238ccSPL set ID a9a590d9-0217-43c7-908d-e62a71279791RxCUI 2107320, 2107325, 2461134, 2461136, 2461139, 2461140UNII C3VX249T6L
- Pharmacologic class
- Complement Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N425682002201followed by a unit qualifier and the quantityPackage 25682-0022-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ULTOMIRIS is a complement inhibitor indicated for: the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH). ( 1.1 ) the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). ( 1.2 ) Limitations of Use: ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. ( 1.3 ) the treatment of adult patients with…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761108
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ultomirisravulizumab | Ravulizumab 1100 mg/11mL | Solution, ConcentrateIntravenous | Alexion Pharmaceuticals Inc. | 25682-028 |
| Ultomirisravulizumab | Ravulizumab 300 mg/3mL | Solution, ConcentrateIntravenous | Alexion Pharmaceuticals Inc. | 25682-025 |