Prescription drug · BLA
Symvess (Acellular tissue engineered vessel) NDC 83564-110
Acellular tissue engineered vessel 420 mm/1 · Implant · Intravascular · Humacyte Global, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83564-110-00 | 83564011000 | 1 BOX in 1 BAG (83564-110-00) / 1 IMPLANT in 1 BOX (83564-110-01)Marketed from Dec 19, 2024 |
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)
- Symvess
- Generic name (nonproprietary)
- acellular tissue engineered vessel
- Active ingredients
- Acellular tissue engineered vessel — 420 mm/1
- Dosage form
- Implant
- Route
- Intravascular
- Labeler
- Humacyte Global, Inc.NDC labeler code 83564
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125812
- Marketing start
- Listing expires
- Identifiers
- Product ID 83564-110_2ca3c2b8-a86b-4e5e-894a-6529e03052e0SPL ID 2ca3c2b8-a86b-4e5e-894a-6529e03052e0SPL set ID 15e9e29f-5aa6-4fc6-b0fe-a48cd1473418RxCUI 2700346, 2700352UNII 6H248RS8YQ
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
N483564011000followed by a unit qualifier and the quantityPackage 83564-0110-00. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
SYMVESS™ is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. SYMVESS™ is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 83564-110
- What is NDC 83564-110?
- 83564-110 is the product NDC for Symvess (acellular tissue engineered vessel), Acellular tissue engineered vessel 420 mm/1 implant, listed with the FDA by Humacyte Global, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Symvess (Acellular tissue engineered vessel).
- What is the active ingredient?
- Acellular tissue engineered vessel.
- Who is the labeler?
- Humacyte Global, Inc., NDC labeler code 83564. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Symvess?
- 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.