Plasma derivative · BLA
Jivi NDC 0026-3944
antihemophilic factor (recombinant) pegylated-aucl · Kit · Bayer HealthCare LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0026-3944-25 | 00026394425 | 1 KIT in 1 BOX (0026-3944-25) * 2.5 mL in 1 VIAL (0026-4944-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4944-01)Marketed from Aug 30, 2018 | |
| 0026-3944-99 | 00026394499 | 1 KIT in 1 BOX (0026-3944-99) * 2.5 mL in 1 VIAL (0026-4944-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4944-01)Marketed from Aug 30, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Jivi
- Generic name (nonproprietary)
- antihemophilic factor (recombinant) pegylated-aucl
- Dosage form
- Kit
- Labeler
- Bayer HealthCare LLC
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125661
- Marketing start
- Listing expires
- Identifiers
- Product ID 0026-3944_15230046-a8a7-4a1c-b279-ae307d278515SPL ID 15230046-a8a7-4a1c-b279-ae307d278515
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.
- NDC on a medical claim
N400026394425followed by a unit qualifier and the quantityPackage 00026-3944-25. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under BLA 125661
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Jiviantihemophilic factor (recombinant) pegylated-aucl | — | Kit | Bayer HealthCare LLC | 0026-3950 |
| Jiviantihemophilic factor (recombinant) pegylated-aucl | — | Kit | Bayer HealthCare LLC | 0026-3942 |
| Jiviantihemophilic factor (recombinant) pegylated-aucl | — | Kit | Bayer HealthCare LLC | 0026-3946 |
| Jiviantihemophilic factor (recombinant) pegylated-aucl | — | Kit | Bayer HealthCare LLC | 0026-3948 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.