NDC codes

FDA NDC Directory
Product NDC (as listed)0169-7013Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00169-7013Add 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
0169-7013-0100169701301001697013011 KIT in 1 KIT (0169-7013-01) * 3 mL in 1 VIAL, GLASS (0169-7113-11) * 3.2 mL in 1 VIAL, GLASS (0169-7000-93)Marketed from Dec 23, 2013

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)
Tretten
Generic name (nonproprietary)
coagulation factor xiii a-subunit (recombinant)
Dosage form
Kit
Labeler
Novo NordiskNDC labeler code 0169
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 125398
Marketing start
Listing expires
Identifiers
Product ID 0169-7013_7e42c015-2e0e-4488-8b8a-3ab37035b2f3SPL ID 7e42c015-2e0e-4488-8b8a-3ab37035b2f3

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

N400169701301 followed by a unit qualifier and the quantity

Package 00169-7013-01. 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 0169-7013

What is NDC 0169-7013?
0169-7013 is the product NDC for Tretten kit, listed with the FDA by Novo Nordisk. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tretten (Coagulation Factor XIII A-Subunit (Recombinant)).
Who is the labeler?
Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tretten?
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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