Prescription drug · BLA
Nexviazyme (Avalglucosidase alfa-ngpt) NDC 58468-0426
Avalglucosidase alfa 100 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Genzyme Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58468-0426-1 | 58468042601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (58468-0426-1) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 6, 2021 |
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)
- Nexviazyme
- Generic name (nonproprietary)
- avalglucosidase alfa-ngpt
- Active ingredients
- Avalglucosidase alfa — 100 mg/10mL
- 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 761194
- Marketing start
- Listing expires
- Other FDA classes
- alpha-Glucosidases (Chemical structure)
- Identifiers
- Product ID 58468-0426_583725c8-1d65-4479-b93b-b945bfe8a39bSPL ID 583725c8-1d65-4479-b93b-b945bfe8a39bSPL set ID 80eb3c9c-01d3-44fe-90ef-81df101b954dRxCUI 2565818, 2565823UNII EO144CP0X9
- Pharmacologic class
- Hydrolytic Lysosomal Glycogen-specific Enzyme
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
N458468042601followed by a unit qualifier and the quantityPackage 58468-0426-01. 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)
NEXVIAZYME is indicated for the treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). NEXVIAZYME is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 58468-0426
- What is NDC 58468-0426?
- 58468-0426 is the product NDC for Nexviazyme (avalglucosidase alfa-ngpt), Avalglucosidase alfa 100 mg/10mL 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?
- Nexviazyme (Avalglucosidase alfa-ngpt).
- What is the active ingredient?
- Avalglucosidase 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 Nexviazyme?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.