Prescription drug · BLA
Encelto (Revakinagene taroretcel-lwey) NDC 82958-501
Revakinagene taroretcel-lwey 440000 [arb'U]/1 · Implant · Intravitreal · Neurotech Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82958-501-01 | 82958050101 | 1 CAPSULE in 1 CONTAINER (82958-501-01) / 1 IMPLANT in 1 CAPSULEMarketed from Mar 12, 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)
- Encelto
- Generic name (nonproprietary)
- revakinagene taroretcel-lwey
- Active ingredients
- Revakinagene taroretcel-lwey — 440000 [arb'U]/1
- Dosage form
- Implant
- Route
- Intravitreal
- Labeler
- Neurotech Pharmaceuticals, Inc.NDC labeler code 82958
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125798
- Marketing start
- Listing expires
- Identifiers
- Product ID 82958-501_943731b7-6b10-4527-ac10-53a5a5e3a5eeSPL ID 943731b7-6b10-4527-ac10-53a5a5e3a5eeSPL set ID 1ae9482a-b478-4e21-9166-b5fd52d3ef9cRxCUI 2708837, 2708843UNII Q7V7NYG6GM
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
N482958050101followed by a unit qualifier and the quantityPackage 82958-0501-01. 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)
ENCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). ENCELTO is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).
Excerpt only. Read the full label for complete information.
About NDC 82958-501
- What is NDC 82958-501?
- 82958-501 is the product NDC for Encelto (revakinagene taroretcel-lwey), Revakinagene taroretcel-lwey 440000 [arb'U]/1 implant, listed with the FDA by Neurotech Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Encelto (Revakinagene taroretcel-lwey).
- What is the active ingredient?
- Revakinagene taroretcel-lwey.
- Who is the labeler?
- Neurotech Pharmaceuticals, Inc., NDC labeler code 82958. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Encelto?
- 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.