Prescription drug · BLA
Epysqli (Eculizumab-aagh) NDC 51759-208
Eculizumab 300 mg/30mL · Injection, Solution · Intravenous · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51759-208-13 | 51759020813 | 1 VIAL, SINGLE-DOSE in 1 CARTON (51759-208-13) / 30 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 7, 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)
- Epysqli
- Generic name (nonproprietary)
- eculizumab-aagh
- Active ingredients
- Eculizumab — 300 mg/30mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 51759
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761340
- Marketing start
- Listing expires
- Other FDA classes
- Complement Inhibitors (Mechanism)
- Identifiers
- Product ID 51759-208_4898d7e0-c6d4-4fd7-8da2-b122296521eaSPL ID 4898d7e0-c6d4-4fd7-8da2-b122296521eaSPL set ID 1fa1aa80-1c59-44d4-9841-b6c52882651bRxCUI 2706338, 2706345UNII 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
N451759020813followed by a unit qualifier and the quantityPackage 51759-0208-13. 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)
EPYSQLI 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 EPYSQLI 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 p…
Excerpt only. Read the full label for complete information.
About NDC 51759-208
- What is NDC 51759-208?
- 51759-208 is the product NDC for Epysqli (eculizumab-aagh), Eculizumab 300 mg/30mL injection, solution, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Epysqli (Eculizumab-aagh).
- What is the active ingredient?
- Eculizumab.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 51759. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Epysqli?
- 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.