NDC codes

FDA NDC Directory
Product NDC (as listed)0944-5001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00944-5001Add 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
0944-5001-0100944500101009445001011 KIT in 1 CARTON (0944-5001-01) * 1 mL in 1 VIAL, GLASS (0944-5011-01) * 1 mL in 1 SYRINGE, GLASS (0944-0011-01)Marketed from Oct 23, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Obizur
Generic name (nonproprietary)
antihemophilic factor (recombinant), porcine sequence
Dosage form
Kit
Labeler
Takeda Pharmaceuticals America, Inc.NDC labeler code 0944
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 125512
Marketing start
Listing expires
Identifiers
Product ID 0944-5001_181004b3-db8d-4be1-a47d-604fd0cff078SPL ID 181004b3-db8d-4be1-a47d-604fd0cff078

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

N400944500101 followed by a unit qualifier and the quantity

Package 00944-5001-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0944-5001

What is NDC 0944-5001?
0944-5001 is the product NDC for Obizur kit, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Obizur (Antihemophilic Factor (Recombinant), Porcine Sequence).
Who is the labeler?
Takeda Pharmaceuticals America, Inc., NDC labeler code 0944. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Obizur?
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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