NDC codes

FDA NDC Directory
Product NDC (as listed)63833-825Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63833-0825Add 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
63833-825-0263833082502638330825021 KIT in 1 CARTON (63833-825-02) * 10 mL in 1 VIAL (63833-835-01) * 10 mL in 1 VIAL (63833-765-15)Marketed from Dec 22, 2011

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)
Berinert
Generic name (nonproprietary)
human c1-esterase inhibitor
Dosage form
Kit
Labeler
CSL Behring GmbHNDC labeler code 63833
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 125287
Marketing start
Listing expires
Identifiers
Product ID 63833-825_6f3826cd-77fd-4ae0-909c-66a91dbe5f72SPL ID 6f3826cd-77fd-4ae0-909c-66a91dbe5f72

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

N463833082502 followed by a unit qualifier and the quantity

Package 63833-0825-02. 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 63833-825

What is NDC 63833-825?
63833-825 is the product NDC for Berinert (human c1-esterase inhibitor) 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?
Berinert (Human c1-esterase inhibitor).
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 Berinert?
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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