Avsola (infliximab-axxq) NDC 55513-670

NDC codes

FDA NDC Directory

Product NDC (as listed)55513-670Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55513-0670Add 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
55513-670-01	55513067001	1 VIAL, SINGLE-DOSE in 1 CARTON (55513-670-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 12, 2019
55513-670-21	55513067021	1 VIAL, SINGLE-DOSE in 1 CARTON (55513-670-21) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 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): Avsola
Generic name (nonproprietary): infliximab-axxq
Active ingredients: Infliximab — 100 mg/10mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Amgen, Inc
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761086
Marketing start: Dec 12, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
Identifiers: Product ID 55513-670_dac3f1a8-101b-46cf-86b7-f289bc764813SPL ID dac3f1a8-101b-46cf-86b7-f289bc764813SPL set ID de34bcb7-b524-45c8-9181-61c6f48d540eRxCUI 2266525, 2266530UNII B72HH48FLU
Pharmacologic class: Tumor Necrosis Factor Blocker

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 codeMed-Code curated

J1745 — Injection, infliximab, excludes biosimilar, 10 mg

Billing unit: 10 mg. Units on the claim = dose given ÷ 10 mg.

Infliximab biosimilars have their own HCPCS codes.

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

N455513067001 followed by a unit qualifier and the quantity

Package 55513-0670-01. 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 22, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

AVSOLA is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.1 ) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. ( 1.1 ) Pediatric Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)