Prescription drug · BLA
Lamzede (Velmanase alfa-tycv) NDC 10122-180
Velmanase alfa-tycv 10 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Chiesi USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10122-180-02 | 10122018002 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-02)Marketed from Mar 1, 2023 | |
| 10122-180-05 | 10122018005 | 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-05)Marketed from Mar 1, 2023 | |
| 10122-180-10 | 10122018010 | 10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-10)Marketed from Mar 1, 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)
- Lamzede
- Generic name (nonproprietary)
- velmanase alfa-tycv
- Active ingredients
- Velmanase alfa-tycv — 10 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Chiesi USA, Inc.NDC labeler code 10122
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761278
- Marketing start
- Listing expires
- Identifiers
- Product ID 10122-180_27cf090b-196e-4330-8184-c72d9bb90660SPL ID 27cf090b-196e-4330-8184-c72d9bb90660SPL set ID 36d50a08-60bd-40eb-807c-778d69bf2d2eRxCUI 2630729, 2630734UNII M91TG242P2
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
N410122018002followed by a unit qualifier and the quantityPackage 10122-0180-02. 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)
1 INDICA TIONS AND USAGE LAMZEDE is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. LAMZEDE is recombinant human lysosomal alpha-mannosidase indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 10122-180
- What is NDC 10122-180?
- 10122-180 is the product NDC for Lamzede (velmanase alfa-tycv), Velmanase alfa-tycv 10 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Chiesi USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamzede (Velmanase alfa-tycv).
- What is the active ingredient?
- Velmanase alfa-tycv.
- 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 Lamzede?
- 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.