Encelto Implant
NDC Package 82958-501-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Encelto (revakinagene taroretcel-lwey) implants is eNCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). This formulation utilizes a implant delivery system. Marketed by Neurotech Pharmaceuticals, Inc., this product is identified by NDC 82958-501 and is authorized under FDA application BLA125798.

Identification & Billing

NDC Package Code
82958-501-01
Package Description
1 CAPSULE in 1 CONTAINER / 1 IMPLANT in 1 CAPSULE
Product Code
82958-501
11-Digit Billing Format
82958050101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 2708837 - revakinagene taroretcel-lwey 200,000 to 440,000 CELLS Intravitreal Implant
  • RxCUI: 2708837 - revakinagene taroretcel-lwey 440000 CELLS Drug Implant
  • RxCUI: 2708843 - ENCELTO 200,000 to 440,000 CELLS Intravitreal Implant
  • RxCUI: 2708843 - revakinagene taroretcel-lwey 440000 CELLS Drug Implant [Encelto]
  • RxCUI: 2708843 - Encelto 200,000 to 440,000 CELLS Intravitreal Implant

Clinical Specifications

Proprietary Name
Encelto
Non-Proprietary Name
Revakinagene Taroretcel-lwey
Substance Name
Revakinagene Taroretcel
Dosage Form
Implant - A material containing drug intended to be inserted securely of deeply in a living site for growth, slow release, or formation of an organic union.
Administration Route
Intravitreal - Administration within the vitreous body of the eye.
Active Ingredient(s)
REVAKINAGENE TARORETCEL 440000 [arb'U]/1
Usage Information
ENCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).

Regulatory & Marketing

Labeler Name
Neurotech Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125798
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-12-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82958-501-01 identifies a specific commercial package of 1 capsule in 1 container / 1 implant in 1 capsule of Encelto, a human prescription drug labeled by Neurotech Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This implant is formulated for intravitreal use and contains revakinagene taroretcel as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Neurotech Pharmaceuticals, Inc. on March 12, 2025. The current certification is valid through December 31, 2026.

How is this Neurotech Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82958050101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
82958-501-01
11-Digit CMS (5-4-2)
82958-0501-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.