Prescription drug · BLA
Xenpozyme (Olipudase alfa-rpcp) NDC 58468-0051
Olipudase alfa 4 mg/1.1mL · Injection, Powder, Lyophilized, For solution · Intravenous · Genzyme Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58468-0051-1 | 58468005101 | 1 VIAL in 1 CARTON (58468-0051-1) / 1.1 mL in 1 VIALMarketed from Aug 29, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Xenpozyme
- Generic name (nonproprietary)
- olipudase alfa-rpcp
- Active ingredients
- Olipudase alfa — 4 mg/1.1mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Genzyme CorporationNDC labeler code 58468
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761261
- Marketing start
- Listing expires
- Identifiers
- Product ID 58468-0051_ce8d4153-ce95-43c4-9672-e1e951ebcdaaSPL ID ce8d4153-ce95-43c4-9672-e1e951ebcdaaSPL set ID 01a910ee-a33e-4be3-ac41-322d64c34311RxCUI 2610411, 2610416, 2634357, 2634359UNII 6D5766Q4OP
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
N458468005101followed by a unit qualifier and the quantityPackage 58468-0051-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. XENPOZYME is a hydrolytic lysosomal sphingomyelin-specific enzyme indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 58468-0051
- What is NDC 58468-0051?
- 58468-0051 is the product NDC for Xenpozyme (olipudase alfa-rpcp), Olipudase alfa 4 mg/1.1mL injection, powder, lyophilized, for solution, listed with the FDA by Genzyme Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xenpozyme (Olipudase alfa-rpcp).
- What is the active ingredient?
- Olipudase alfa.
- Who is the labeler?
- Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xenpozyme?
- 1 other product NDC are listed under this name. See all Xenpozyme NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xenpozyme products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xenpozymeolipudase alfa-rpcp | Olipudase alfa 20 mg/5.1mL | Injection, Powder, Lyophilized, For solutionIntravenous | Genzyme Corporation | 58468-0050 | 58468-0050-01 |
Other NDCs under BLA 761261
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 |
|---|---|---|---|---|
| Xenpozymeolipudase alfa-rpcp | Olipudase alfa 20 mg/5.1mL | Injection, Powder, Lyophilized, For solutionIntravenous | Genzyme Corporation | 58468-0050 |