NDC codes

FDA NDC Directory
Product NDC (as listed)63833-616Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63833-0616Add 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
63833-616-02638330616021 KIT in 1 CARTON (63833-616-02) * 10 mL in 1 VIAL (63833-626-01) * 10 mL in 1 VIAL, SINGLE-DOSE (63833-765-54)Marketed from May 1, 1986

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)
Humate-P
Generic name (nonproprietary)
antihemophilic factor/von willebrand factor complex (human)
Dosage form
Kit
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 103960
Marketing start
Listing expires
Identifiers
Product ID 63833-616_3fefdbbb-c86f-4ed6-b4f0-73bcad062e01SPL ID 3fefdbbb-c86f-4ed6-b4f0-73bcad062e01

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

N463833061602 followed by a unit qualifier and the quantity

Package 63833-0616-02. 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.

Other NDCs under BLA 103960

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

FDA NDC Directory listings under BLA 103960
ProductStrengthForm · routeLabelerProduct NDC
Humate-Pantihemophilic factor/von willebrand factor complex (human)—KitCSL Behring GmbH63833-615
Humate-Pantihemophilic factor/von willebrand factor complex (human)—KitCSL Behring GmbH63833-617

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