Plasma derivative · BLA
Kovaltry (Antihemophilic factor (recombinant)) NDC 0026-3821
Kit · Bayer HealthCare LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0026-3821-25 | 0002638212500026382125 | 1 KIT in 1 BOX (0026-3821-25) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01)Marketed from Mar 17, 2016 | |
| 0026-3821-99 | 0002638219900026382199 | 1 KIT in 1 BOX (0026-3821-99) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01)Marketed from Mar 17, 2016 |
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)
- Kovaltry
- Generic name (nonproprietary)
- antihemophilic factor (recombinant)
- Dosage form
- Kit
- Labeler
- Bayer HealthCare LLCNDC labeler code 0026
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125574
- Marketing start
- Listing expires
- Identifiers
- Product ID 0026-3821_f4bed724-db3e-448e-8947-2f6a6913f1eeSPL ID f4bed724-db3e-448e-8947-2f6a6913f1ee
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
N400026382125followed by a unit qualifier and the quantityPackage 00026-3821-25. 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.
About NDC 0026-3821
- What is NDC 0026-3821?
- 0026-3821 is the product NDC for Kovaltry (antihemophilic factor (recombinant)) kit, listed with the FDA by Bayer HealthCare LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kovaltry (Antihemophilic Factor (Recombinant)).
- Who is the labeler?
- Bayer HealthCare LLC, NDC labeler code 0026. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kovaltry?
- 4 other product NDCs are listed under this name. See all Kovaltry NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kovaltry products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kovaltryantihemophilic factor (recombinant) | — | Kit | Bayer HealthCare LLC | 0026-3822 | 00026-3822-2500026-3822-99 |
| Kovaltryantihemophilic factor (recombinant) | — | Kit | Bayer HealthCare LLC | 0026-3824 | 00026-3824-2500026-3824-99 |
| Kovaltryantihemophilic factor (recombinant) | — | Kit | Bayer HealthCare LLC | 0026-3826 | 00026-3826-5000026-3826-99 |
| Kovaltryantihemophilic factor (recombinant) | — | Kit | Bayer HealthCare LLC | 0026-3828 | 00026-3828-5000026-3828-99 |
Other NDCs under BLA 125574
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 |
|---|---|---|---|---|
| Kovaltryantihemophilic factor (recombinant) | — | Kit | Bayer HealthCare LLC | 0026-3822 |
| Kovaltryantihemophilic factor (recombinant) | — | Kit | Bayer HealthCare LLC | 0026-3824 |
| Kovaltryantihemophilic factor (recombinant) | — | Kit | Bayer HealthCare LLC | 0026-3826 |
| Kovaltryantihemophilic factor (recombinant) | — | Kit | Bayer HealthCare LLC | 0026-3828 |