United States · FDA National Drug Code directory
ELFABRIO
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 10122-160_ca12aa63-7344-4996-bfb4-d2289c245f4a
- Product NDC
- 10122-160
- Form
- INJECTION, SOLUTION, CONCENTRATE
- Composition / generic term
- pegunigalsidase alfa
- Labeler
- Chiesi USA, Inc.
- Marketing category
- BLA
- Marketing start / end (source format)
- 20230523
- Source listing expiry
- 20261231
Source-listed ingredients
- PEGUNIGALSIDASE ALFA — 20 mg/10mL
These values do not establish equivalence or a dose recommendation.
Packages
- 1 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-02) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01) · 10122-160-02
- 5 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-05) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01) · 10122-160-05
- 10 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-10) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01) · 10122-160-10
Source and coverage
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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
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