Prescription drug · BLA
Crysvita (burosumab) NDC 42747-102
Burosumab 10 mg/mL · Injection · Subcutaneous · Kyowa Kirin, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42747-102-01 | 42747010201 | 1 VIAL, SINGLE-USE in 1 CARTON (42747-102-01) / 1 mL in 1 VIAL, SINGLE-USEMarketed from Sep 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)
- Crysvita
- Generic name (nonproprietary)
- burosumab
- Active ingredients
- Burosumab — 10 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Kyowa Kirin, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761068
- Marketing start
- Listing expires
- Identifiers
- Product ID 42747-102_763f89b2-723c-410d-b3b6-cc001c16c3caSPL ID 763f89b2-723c-410d-b3b6-cc001c16c3caSPL set ID 102f96a0-6e3a-4fc1-b204-34d604683af6RxCUI 2043859, 2043864, 2043868, 2043870, 2043876, 2043878UNII G9WJT6RD29
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
N442747010201followed by a unit qualifier and the quantityPackage 42747-0102-01. 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 .
Indications (excerpt from the label)
CRYSVITA is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for: The treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. ( 1.1 ) The treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older. ( 1.2 ) 1.1 X-linked Hypophosphatemia CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. 1.2 Tumor-induced Osteomalacia CRYSVITA is indicated for the treatment of FGF23-related hyp…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761068
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.