NDC codes

FDA NDC Directory
Product NDC (as listed)58468-0225Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58468-0225Add 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
58468-0225-1584680225011 KIT in 1 CARTON (58468-0225-1) * 1 mL in 1 VIAL, GLASS (58468-0227-1) * 1 mL in 1 SYRINGE, GLASS (58468-0229-1)Marketed from Feb 6, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Cablivi
Generic name (nonproprietary)
caplacizumab
Dosage form
Kit
Labeler
Genzyme CorporationNDC labeler code 58468
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 761112
Marketing start
Listing expires
Identifiers
Product ID 58468-0225_545bfe88-5343-4f25-a107-5b9bcc2e45a4SPL ID 545bfe88-5343-4f25-a107-5b9bcc2e45a4SPL set ID 2348f06e-8004-4040-832e-e9e86a39f905RxCUI 2110616, 2110618

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

N458468022501 followed by a unit qualifier and the quantity

Package 58468-0225-01. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

CABLIVI is indicated for the treatment of adult and pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. CABLIVI is a von Willebrand factor (vWF)-directed antibody fragment indicated for the treatment of adult and pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58468-0225

What is NDC 58468-0225?
58468-0225 is the product NDC for Cablivi (caplacizumab) kit, listed with the FDA by Genzyme Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cablivi (Caplacizumab).
Who is the labeler?
Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cablivi?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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