Prescription drug · BLA
Mepsevii (vestronidase alfa) NDC 69794-001
Vestronidase alfa 2 mg/mL · Injection · Intravenous · Ultragenyx Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69794-001-01 | 69794000101 | 1 VIAL, SINGLE-USE in 1 CARTON (69794-001-01) / 5 mL in 1 VIAL, SINGLE-USEMarketed from Nov 15, 2017 |
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)
- Mepsevii
- Generic name (nonproprietary)
- vestronidase alfa
- Active ingredients
- Vestronidase alfa — 2 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761047
- Marketing start
- Listing expires
- Identifiers
- Product ID 69794-001_6e20f052-5a5f-41cd-ab55-97b8a9bf6562SPL ID 6e20f052-5a5f-41cd-ab55-97b8a9bf6562SPL set ID 925d4e21-fd98-474d-a34d-a0b3558ed750RxCUI 1989823, 1989828UNII 7XZ4062R17
- Pharmacologic class
- Lysosomal beta Glucuronidase
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
N469794000101followed by a unit qualifier and the quantityPackage 69794-0001-01. 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)
MEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). Limitations of Use The effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined. MEPSEVII is a recombinant human lysosomal beta glucuronidase indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). Limitations of Use The effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined. ( 1 )
Excerpt only. Read the full label for complete information.