Plasma derivative · BLA
Fesilty (Fibrinogen, human-chmt) NDC 13533-502
Kit · Grifols USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13533-502-01 | 13533050201 | 1 KIT in 1 CARTON (13533-502-01) * 50 mL in 1 VIAL, GLASS (13533-503-02) * 50 mL in 1 VIAL, GLASS (13533-200-50)Marketed from Dec 16, 2025 |
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)
- Fesilty
- Generic name (nonproprietary)
- fibrinogen, human-chmt
- Dosage form
- Kit
- Labeler
- Grifols USA LLCNDC labeler code 13533
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125833
- Marketing start
- Listing expires
- Identifiers
- Product ID 13533-502_be4e2748-8d18-4593-9855-c2c4f3faba3eSPL ID be4e2748-8d18-4593-9855-c2c4f3faba3e
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
N413533050201followed by a unit qualifier and the quantityPackage 13533-0502-01. 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 13533-502
- What is NDC 13533-502?
- 13533-502 is the product NDC for Fesilty kit, listed with the FDA by Grifols USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fesilty (Fibrinogen, human-chmt).
- Who is the labeler?
- Grifols USA LLC, NDC labeler code 13533. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fesilty?
- 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.