NDC codes

FDA NDC Directory
Product NDC (as listed)82958-501Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82958-0501Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
82958-501-01829580501011 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

N482958050101 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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