Plasma derivative · BLA
Novoeight (Antihemophilic factor recombinant) NDC 0169-7850
Kit · Novo Nordisk
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-7850-01 | 00169785001 | 1 KIT in 1 KIT (0169-7850-01) * 4 mL in 1 VIAL, GLASS (0169-7851-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98)Marketed from Apr 1, 2015 |
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)
- Novoeight
- Generic name (nonproprietary)
- antihemophilic factor recombinant
- Dosage form
- Kit
- Labeler
- Novo NordiskNDC labeler code 0169
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125466
- Marketing start
- Listing expires
- Identifiers
- Product ID 0169-7850_590d35a4-6e12-450e-9508-0c5bbf2ac427SPL ID 590d35a4-6e12-450e-9508-0c5bbf2ac427
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
N400169785001followed by a unit qualifier and the quantityPackage 00169-7850-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0169-7850
- What is NDC 0169-7850?
- 0169-7850 is the product NDC for Novoeight (antihemophilic factor recombinant) kit, listed with the FDA by Novo Nordisk. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Novoeight (Antihemophilic factor recombinant).
- Who is the labeler?
- Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Novoeight?
- 5 other product NDCs are listed under this name. See all Novoeight NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Novoeight products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Novoeightantihemophilic factor recombinant | — | Kit | Novo Nordisk | 0169-7810 | 00169-7810-01 |
| Novoeightantihemophilic factor recombinant | — | Kit | Novo Nordisk | 0169-7815 | 00169-7815-01 |
| Novoeightantihemophilic factor recombinant | — | Kit | Novo Nordisk | 0169-7820 | 00169-7820-01 |
| Novoeightantihemophilic factor recombinant | — | Kit | Novo Nordisk | 0169-7825 | 00169-7825-01 |
| Novoeightantihemophilic factor recombinant | — | Kit | Novo Nordisk | 0169-7830 | 00169-7830-01 |
Other NDCs under BLA 125466
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 |
|---|---|---|---|---|
| Novoeightantihemophilic factor recombinant | — | Kit | Novo Nordisk | 0169-7810 |
| Novoeightantihemophilic factor recombinant | — | Kit | Novo Nordisk | 0169-7815 |
| Novoeightantihemophilic factor recombinant | — | Kit | Novo Nordisk | 0169-7820 |
| Novoeightantihemophilic factor recombinant | — | Kit | Novo Nordisk | 0169-7825 |
| Novoeightantihemophilic factor recombinant | — | Kit | Novo Nordisk | 0169-7830 |