Prescription drug · BLA
Voyxact (Sibeprenlimab) NDC 59148-400
Sibeprenlimab 200 mg/mL · Injection · Subcutaneous · Otsuka America Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59148-400-75 | 59148040075 | 1 SYRINGE in 1 CARTON (59148-400-75) / 2 mL in 1 SYRINGEMarketed from Nov 25, 2025 |
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)
- Voyxact
- Generic name (nonproprietary)
- sibeprenlimab
- Active ingredients
- Sibeprenlimab — 200 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Otsuka America Pharmaceutical, Inc.NDC labeler code 59148
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761434
- Marketing start
- Listing expires
- Identifiers
- Product ID 59148-400_9aa886b0-669e-48d4-9f37-a160d78f69c6SPL ID 9aa886b0-669e-48d4-9f37-a160d78f69c6SPL set ID c8a93b32-0676-4704-86dc-cb65f425c6e5RxCUI 2728400, 2728407UNII GHX28QZ7DD
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
N459148040075followed by a unit qualifier and the quantityPackage 59148-0400-75. 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)
VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. VOYXACT is an A Proliferation Inducing Ligand (APRIL) blocker, indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. ( 1 ) This indication is ap…
Excerpt only. Read the full label for complete information.
About NDC 59148-400
- What is NDC 59148-400?
- 59148-400 is the product NDC for Voyxact (sibeprenlimab), Sibeprenlimab 200 mg/mL injection, listed with the FDA by Otsuka America Pharmaceutical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Voyxact (Sibeprenlimab).
- What is the active ingredient?
- Sibeprenlimab.
- Who is the labeler?
- Otsuka America Pharmaceutical, Inc., NDC labeler code 59148. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Voyxact?
- 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.