Prescription drug · BLA
Elfabrio (pegunigalsidase alfa) NDC 10122-160
Pegunigalsidase alfa 20 mg/10mL · Injection, Solution, Concentrate · Intravenous · Chiesi USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10122-160-02 | 10122016002 | 1 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-02) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)Marketed from May 23, 2023 | |
| 10122-160-05 | 10122016005 | 5 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-05) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)Marketed from May 23, 2023 | |
| 10122-160-10 | 10122016010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-10) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)Marketed from May 23, 2023 |
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)
- Elfabrio
- Generic name (nonproprietary)
- pegunigalsidase alfa
- Active ingredients
- Pegunigalsidase alfa — 20 mg/10mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Chiesi USA, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761161
- Marketing start
- Listing expires
- Identifiers
- Product ID 10122-160_ca12aa63-7344-4996-bfb4-d2289c245f4aSPL ID ca12aa63-7344-4996-bfb4-d2289c245f4aSPL set ID 6fb674bf-744e-431f-92ef-b2a5a66c8cf3RxCUI 2637456, 2637462, 2676759, 2676760UNII 8M7V7Q6537
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
N410122016002followed by a unit qualifier and the quantityPackage 10122-0160-02. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.