Plasma derivative · BLA
Kcentra NDC 63833-386
Kit · CSL Behring GmbH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63833-386-02 | 6383303860263833038602 | 1 KIT in 1 CARTON (63833-386-02) * 20 mL in 1 VIAL, SINGLE-USE (63833-396-01) * 20 mL in 1 VIAL, SINGLE-USE (63833-761-20)Marketed from Apr 29, 2013 |
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)
- Kcentra
- Generic name (nonproprietary)
- prothrombin, coagulation factor vii human, coagulation factor ix human, coagulation factor x human, protein c, protein s human, and water
- Dosage form
- Kit
- Labeler
- CSL Behring GmbHNDC labeler code 63833
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125421
- Marketing start
- Listing expires
- Identifiers
- Product ID 63833-386_bf67ad30-c0b2-456a-beda-f65ee1830c3fSPL ID bf67ad30-c0b2-456a-beda-f65ee1830c3f
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
N463833038602followed by a unit qualifier and the quantityPackage 63833-0386-02. 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 63833-386
- What is NDC 63833-386?
- 63833-386 is the product NDC for Kcentra kit, listed with the FDA by CSL Behring GmbH. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kcentra (PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, Protein C, Protein S Human, and Water).
- Who is the labeler?
- CSL Behring GmbH, NDC labeler code 63833. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kcentra?
- 1 other product NDC are listed under this name. See all Kcentra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kcentra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kcentraprothrombin, coagulation factor vii human, coagulation factor ix human, coagulation factor x human, protein c, protein s human, and water | — | Kit | CSL Behring GmbH | 63833-387 | 63833-0387-02 |
Other NDCs under BLA 125421
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 |
|---|---|---|---|---|
| Kcentraprothrombin, coagulation factor vii human, coagulation factor ix human, coagulation factor x human, protein c, protein s human, and water | — | Kit | CSL Behring GmbH | 63833-387 |