Plasma derivative · BLA
Tretten NDC 0169-7013
coagulation factor xiii a-subunit (recombinant) · Kit · Novo Nordisk
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-7013-01 | 0016970130100169701301 | 1 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
N400169701301followed by a unit qualifier and the quantityPackage 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.