Plasma derivative · BLA
Esperoct NDC 0169-8400
antihemophilic factor (recombinant), glycopegylated-exei · Kit · Novo Nordisk
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-8400-01 | 00169840001 | 1 KIT in 1 KIT (0169-8400-01) * 4 mL in 1 VIAL, GLASS (0169-8401-11) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98)Marketed from Feb 19, 2019 |
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)
- Esperoct
- Generic name (nonproprietary)
- antihemophilic factor (recombinant), glycopegylated-exei
- Dosage form
- Kit
- Labeler
- Novo NordiskNDC labeler code 0169
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125671
- Marketing start
- Listing expires
- Identifiers
- Product ID 0169-8400_d47af230-b125-4bd9-b36c-51e8f90b22bcSPL ID d47af230-b125-4bd9-b36c-51e8f90b22bc
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
N400169840001followed by a unit qualifier and the quantityPackage 00169-8400-01. 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 0169-8400
- What is NDC 0169-8400?
- 0169-8400 is the product NDC for Esperoct 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?
- Esperoct (Antihemophilic factor (recombinant), glycopegylated-exei).
- 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 Esperoct?
- 6 other product NDCs are listed under this name. See all Esperoct NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Esperoct products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Esperoctantihemophilic factor (recombinant), glycopegylated-exei | — | Kit | Novo Nordisk | 0169-8055 | 00169-8055-01 |
| Esperoctantihemophilic factor (recombinant), glycopegylated-exei | — | Kit | Novo Nordisk | 0169-8100 | 00169-8100-0100169-8100-93 |
| Esperoctantihemophilic factor (recombinant), glycopegylated-exei | — | Kit | Novo Nordisk | 0169-8150 | 00169-8150-01 |
| Esperoctantihemophilic factor (recombinant), glycopegylated-exei | — | Kit | Novo Nordisk | 0169-8200 | 00169-8200-01 |
| Esperoctantihemophilic factor (recombinant), glycopegylated-exei | — | Kit | Novo Nordisk | 0169-8300 | 00169-8300-0100169-8300-93 |
| Esperoctantihemophilic factor (recombinant), glycopegylated-exei | — | Kit | Novo Nordisk | 0169-8500 | 00169-8500-0100169-8500-93 |
Other NDCs under BLA 125671
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 |
|---|---|---|---|---|
| Esperoctantihemophilic factor (recombinant), glycopegylated-exei | — | Kit | Novo Nordisk | 0169-8055 |
| Esperoctantihemophilic factor (recombinant), glycopegylated-exei | — | Kit | Novo Nordisk | 0169-8100 |
| Esperoctantihemophilic factor (recombinant), glycopegylated-exei | — | Kit | Novo Nordisk | 0169-8150 |
| Esperoctantihemophilic factor (recombinant), glycopegylated-exei | — | Kit | Novo Nordisk | 0169-8200 |
| Esperoctantihemophilic factor (recombinant), glycopegylated-exei | — | Kit | Novo Nordisk | 0169-8300 |
| Esperoctantihemophilic factor (recombinant), glycopegylated-exei | — | Kit | Novo Nordisk | 0169-8500 |