NDC codes

FDA NDC Directory
Product NDC (as listed)63833-386Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63833-0386Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
63833-386-0263833038602638330386021 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

N463833038602 followed by a unit qualifier and the quantity

Package 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Kcentra NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Kcentraprothrombin, coagulation factor vii human, coagulation factor ix human, coagulation factor x human, protein c, protein s human, and water—KitCSL Behring GmbH63833-38763833-0387-02

Other NDCs under BLA 125421

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125421
ProductStrengthForm · routeLabelerProduct NDC
Kcentraprothrombin, coagulation factor vii human, coagulation factor ix human, coagulation factor x human, protein c, protein s human, and water—KitCSL Behring GmbH63833-387

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