ELFABRIO

NDC 10122-165 · Chiesi USA, Inc.

Generic namepegunigalsidase alfa

Dosage formINJECTION, SOLUTION, CONCENTRATE

RouteINTRAVENOUS

Active ingredient(s)PEGUNIGALSIDASE ALFA

Strength5 mg/2.5mL

Marketing categoryBLA

Packages

10122-165-02 — 1 VIAL, SINGLE-DOSE in 1 CARTON (10122-165-02) / 2.5 mL in 1 VIAL, SINGLE-DOSE

J2508 — Injection, pegunigalsidase alfa-iwxj, 1 mg Medicare Part B payment limit (ASP + 6%): $225.66

FDA lists these products with the same active ingredient.

10122-160 — pegunigalsidase alfa

From the FDA National Drug Code Directory, retrieved 2026-08-24. Product listings are submitted by labelers; FDA does not verify them.