Prescription drug · BLA
Elfabrio (Pegunigalsidase alfa) NDC 10122-165
Pegunigalsidase alfa 5 mg/2.5mL · Injection, Solution, Concentrate · Intravenous · Chiesi USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10122-165-02 | 1012201650210122016502 | 1 VIAL, SINGLE-DOSE in 1 CARTON (10122-165-02) / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 8, 2024 |
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 — 5 mg/2.5mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Chiesi USA, Inc.NDC labeler code 10122
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761161
- Marketing start
- Listing expires
- Identifiers
- Product ID 10122-165_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
N410122016502followed by a unit qualifier and the quantityPackage 10122-0165-02. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ELFABRIO is indicated for the treatment of adults with confirmed Fabry disease. ELFABRIO is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adults with confirmed Fabry disease. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 10122-165
- What is NDC 10122-165?
- 10122-165 is the product NDC for Elfabrio (pegunigalsidase alfa), Pegunigalsidase alfa 5 mg/2.5mL injection, solution, concentrate, listed with the FDA by Chiesi USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Elfabrio (Pegunigalsidase alfa).
- What is the active ingredient?
- Pegunigalsidase alfa.
- Who is the labeler?
- Chiesi USA, Inc., NDC labeler code 10122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Elfabrio?
- 1 other product NDC are listed under this name. See all Elfabrio NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Elfabrio products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Elfabriopegunigalsidase alfa | Pegunigalsidase alfa 20 mg/10mL | Injection, Solution, ConcentrateIntravenous | Chiesi USA, Inc. | 10122-160 | 10122-0160-0210122-0160-0510122-0160-10 |
Other NDCs under BLA 761161
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Elfabriopegunigalsidase alfa | Pegunigalsidase alfa 20 mg/10mL | Injection, Solution, ConcentrateIntravenous | Chiesi USA, Inc. | 10122-160 |