Prescription drug · BLA
Alhemo (Concizumab) NDC 0169-2080
Concizumab 100 mg/mL · Injection, Solution · Subcutaneous · Novo Nordisk
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-2080-15 | 00169208015 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-2080-15) / 1.5 mL in 1 SYRINGE, PLASTICMarketed from Feb 19, 2025 |
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)
- Alhemo
- Generic name (nonproprietary)
- concizumab
- Active ingredients
- Concizumab — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Novo NordiskNDC labeler code 0169
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761315
- Marketing start
- Listing expires
- Other FDA classes
- Tissue Factor Pathway Inhibitor Antagonists (Mechanism)
- Identifiers
- Product ID 0169-2080_ff2589ac-650f-4740-984d-e950f785c1fcSPL ID ff2589ac-650f-4740-984d-e950f785c1fcSPL set ID 156f6404-1f6f-417f-bcf8-f07a27a82cc1RxCUI 2708346, 2708353, 2708356, 2708359, 2708361, 2708362UNII 68603V9EAF
- Pharmacologic class
- Tissue Factor Pathway Inhibitor Antagonist
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
N400169208015followed by a unit qualifier and the quantityPackage 00169-2080-15. 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)
Alhemo is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors • hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors Alhemo is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors • hemophilia B (congenital factor IX deficiency) with or without FIX inh…
Excerpt only. Read the full label for complete information.
About NDC 0169-2080
- What is NDC 0169-2080?
- 0169-2080 is the product NDC for Alhemo (concizumab), Concizumab 100 mg/mL injection, solution, 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?
- Alhemo (Concizumab).
- What is the active ingredient?
- Concizumab.
- 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 Alhemo?
- 2 other product NDCs are listed under this name. See all Alhemo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alhemo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alhemoconcizumab | Concizumab 100 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-2081 | 00169-2081-03 |
| Alhemoconcizumab | Concizumab 40 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-2084 | 00169-2084-15 |
Other NDCs under BLA 761315
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 |
|---|---|---|---|---|
| Alhemoconcizumab | Concizumab 100 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-2081 |
| Alhemoconcizumab | Concizumab 40 mg/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-2084 |