Prescription drug · BLA
Avance Nerve Graft (Processed nerve allograft) NDC 84545-350
Human peripheral nerve tissue 3 mm/50mm · Implant · Soft tissue · Axogen Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84545-350-01 | 84545035001 | 1 CARTON in 1 BAG (84545-350-01) / 1 POUCH in 1 CARTON / 1 POUCH in 1 POUCH / 1 CONTAINER in 1 POUCH / 1 mm in 1 CONTAINERMarketed from Apr 6, 2026 |
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)
- Avance Nerve Graft
- Generic name (nonproprietary)
- processed nerve allograft
- Active ingredients
- Human peripheral nerve tissue — 3 mm/50mm
- Dosage form
- Implant
- Route
- Soft tissue
- Labeler
- Axogen CorporationNDC labeler code 84545
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125816
- Marketing start
- Listing expires
- Identifiers
- Product ID 84545-350_5c0c36c2-0dcf-4762-8653-31805880f668SPL ID 5c0c36c2-0dcf-4762-8653-31805880f668SPL set ID e50d90fa-83ef-4d1b-9691-2b9c7bbdc2aeRxCUI 2749421, 2749427UNII 725P2LR8RG
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N484545035001followed by a unit qualifier and the quantityPackage 84545-0350-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
AVANCE is an acellular nerve scaffold indicated for the treatment of adult and pediatric patients aged one month and older with: • Sensory nerve discontinuity (≤25 mm). ( 1 ) • Sensory nerve discontinuity (>25 mm). This indication is approved under accelerated approval based on static two-point discrimination (s2PD) at 12 months in sensory nerve gaps ≤25 mm, which provided empirical evidence to reasonably predict clinical benefit given similarities in pathophysiology and anticipated therapeutic effects. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. ( 1 , 14 ) • Mixed and motor nerve discontinui…
Excerpt only. Read the full label for complete information.
About NDC 84545-350
- What is NDC 84545-350?
- 84545-350 is the product NDC for Avance Nerve Graft (processed nerve allograft), Human peripheral nerve tissue 3 mm/50mm implant, listed with the FDA by Axogen Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Avance Nerve Graft (Processed nerve allograft).
- What is the active ingredient?
- Human peripheral nerve tissue.
- Who is the labeler?
- Axogen Corporation, NDC labeler code 84545. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Avance Nerve Graft?
- 15 other product NDCs are listed under this name. See all Avance Nerve Graft NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Avance Nerve Graft products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 1 mm/15mm | ImplantSoft tissue | Axogen Corporation | 84545-115 | 84545-0115-01 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 1 mm/30mm | ImplantSoft tissue | Axogen Corporation | 84545-130 | 84545-0130-01 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 1 mm/50mm | ImplantSoft tissue | Axogen Corporation | 84545-150 | 84545-0150-01 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 1 mm/70mm | ImplantSoft tissue | Axogen Corporation | 84545-170 | 84545-0170-01 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 2 mm/15mm | ImplantSoft tissue | Axogen Corporation | 84545-215 | 84545-0215-01 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 2 mm/30mm | ImplantSoft tissue | Axogen Corporation | 84545-230 | 84545-0230-01 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 2 mm/50mm | ImplantSoft tissue | Axogen Corporation | 84545-250 | 84545-0250-01 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 2 mm/70mm | ImplantSoft tissue | Axogen Corporation | 84545-270 | 84545-0270-01 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 3 mm/15mm | ImplantSoft tissue | Axogen Corporation | 84545-315 | 84545-0315-01 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 3 mm/30mm | ImplantSoft tissue | Axogen Corporation | 84545-330 | 84545-0330-01 |
Other NDCs under BLA 125816
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 1 mm/15mm | ImplantSoft tissue | Axogen Corporation | 84545-115 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 1 mm/30mm | ImplantSoft tissue | Axogen Corporation | 84545-130 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 1 mm/50mm | ImplantSoft tissue | Axogen Corporation | 84545-150 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 1 mm/70mm | ImplantSoft tissue | Axogen Corporation | 84545-170 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 2 mm/15mm | ImplantSoft tissue | Axogen Corporation | 84545-215 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 2 mm/30mm | ImplantSoft tissue | Axogen Corporation | 84545-230 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 2 mm/50mm | ImplantSoft tissue | Axogen Corporation | 84545-250 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 2 mm/70mm | ImplantSoft tissue | Axogen Corporation | 84545-270 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 3 mm/15mm | ImplantSoft tissue | Axogen Corporation | 84545-315 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 3 mm/30mm | ImplantSoft tissue | Axogen Corporation | 84545-330 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 3 mm/70mm | ImplantSoft tissue | Axogen Corporation | 84545-370 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 4 mm/15mm | ImplantSoft tissue | Axogen Corporation | 84545-415 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 4 mm/30mm | ImplantSoft tissue | Axogen Corporation | 84545-430 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 4 mm/50mm | ImplantSoft tissue | Axogen Corporation | 84545-450 |
| Avance Nerve Graftprocessed nerve allograft | Human peripheral nerve tissue 4 mm/70mm | ImplantSoft tissue | Axogen Corporation | 84545-470 |