What is NDC 25682-001?

25682-001 is the product NDC for Soliris (eculizumab), Eculizumab 300 mg/30mL injection, solution, concentrate, listed with the FDA by Alexion Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Alexion Pharmaceuticals Inc., NDC labeler code 25682. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Soliris?

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.

Soliris NDC 25682-001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)25682-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25682-0001Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
25682-001-01	25682000101	1 VIAL in 1 CARTON (25682-001-01) / 30 mL in 1 VIALMarketed from Apr 2, 2007

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): Soliris
Generic name (nonproprietary): eculizumab
Active ingredients: Eculizumab — 300 mg/30mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: Alexion Pharmaceuticals Inc.NDC labeler code 25682
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125166
Marketing start: Apr 2, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Complement Inhibitors (Mechanism)
Identifiers: Product ID 25682-001_acc88f23-0e1f-44f9-be2f-059565a5e25eSPL ID acc88f23-0e1f-44f9-be2f-059565a5e25eSPL set ID ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722RxCUI 700384, 700387UNII 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.

How CPT relates to drug billing

NDC on a medical claim

N425682000101 followed by a unit qualifier and the quantity

Package 25682-0001-01. 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 Jul 8, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

SOLIRIS 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 SOLIRIS 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 and pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive. ( 1.3 ) the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients w…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 25682-001

What is NDC 25682-001?: 25682-001 is the product NDC for Soliris (eculizumab), Eculizumab 300 mg/30mL injection, solution, concentrate, listed with the FDA by Alexion Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Soliris (Eculizumab).
What is the active ingredient?: Eculizumab.
Who is the labeler?: Alexion Pharmaceuticals Inc., NDC labeler code 25682. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Soliris?: 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.

Soliris (Eculizumab) NDC 25682-001