Prescription drug · BLA
Bkemv (Eculizumab-aeeb) NDC 55513-180
Eculizumab 300 mg/30mL · Injection, Solution, Concentrate · Intravenous · Amgen Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-180-01 | 5551301800155513018001 | 1 VIAL in 1 CARTON (55513-180-01) / 30 mL in 1 VIALMarketed from Mar 1, 2025 |
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)
- Bkemv
- Generic name (nonproprietary)
- eculizumab-aeeb
- Active ingredients
- Eculizumab — 300 mg/30mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Amgen IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761333
- Marketing start
- Listing expires
- Other FDA classes
- Complement Inhibitors (Mechanism)
- Identifiers
- Product ID 55513-180_d7cfaa27-0f0d-4f4f-934d-32be84291d85SPL ID d7cfaa27-0f0d-4f4f-934d-32be84291d85SPL set ID 002f9748-b0e8-4b6e-a38b-56930a839491RxCUI 2706351, 2706358UNII A3ULP0F556
- 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
N455513018001followed by a unit qualifier and the quantityPackage 55513-0180-01. 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)
BKEMV is a complement inhibitor indicated for: The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. ( 1.1 ) The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. ( 1.2 ) Limitation of Use BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). The treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ( 1.3 ) The treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody posit…
Excerpt only. Read the full label for complete information.
About NDC 55513-180
- What is NDC 55513-180?
- 55513-180 is the product NDC for Bkemv (eculizumab-aeeb), Eculizumab 300 mg/30mL injection, solution, concentrate, listed with the FDA by Amgen Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bkemv (Eculizumab-aeeb).
- What is the active ingredient?
- Eculizumab.
- Who is the labeler?
- Amgen Inc, NDC labeler code 55513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bkemv?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.