Prescription drug · BLA
Takhzyro (Lanadelumab-flyo) NDC 47783-646
Lanadelumab 300 mg/2mL · Solution · Subcutaneous · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47783-646-01 | 4778306460147783064601 | 1 SYRINGE, GLASS in 1 CARTON (47783-646-01) / 2 mL in 1 SYRINGE, GLASSMarketed from Feb 8, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Takhzyro
- Generic name (nonproprietary)
- lanadelumab-flyo
- Active ingredients
- Lanadelumab — 300 mg/2mL
- Dosage form
- Solution
- Route
- Subcutaneous
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 47783
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761090
- Marketing start
- Listing expires
- Other FDA classes
- Kallikrein Inhibitors (Mechanism)
- Identifiers
- Product ID 47783-646_17d1082c-b049-4d08-a7e9-4625ed80656aSPL ID 17d1082c-b049-4d08-a7e9-4625ed80656a
- Pharmacologic class
- Plasma Kallikrein Inhibitor
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
N447783064601followed by a unit qualifier and the quantityPackage 47783-0646-01. 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 47783-646
- What is NDC 47783-646?
- 47783-646 is the product NDC for Takhzyro (lanadelumab-flyo), Lanadelumab 300 mg/2mL solution, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Takhzyro (Lanadelumab-flyo).
- What is the active ingredient?
- Lanadelumab.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 47783. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Takhzyro?
- 1 other product NDC are listed under this name. See all Takhzyro NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Takhzyro products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Takhzyrolanadelumab-flyo | Lanadelumab 150 mg/mL | SolutionSubcutaneous | Takeda Pharmaceuticals America, Inc. | 47783-645 | 47783-0645-01 |
Other NDCs under BLA 761090
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 |
|---|---|---|---|---|
| Takhzyrolanadelumab-flyo | Lanadelumab 150 mg/mL | SolutionSubcutaneous | Takeda Pharmaceuticals America, Inc. | 47783-645 |