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  5. NDC Package Code: 82958-501-01 Encelto

NDC Package 82958-501-01 Encelto

Revakinagene Taroretcel-lwey Implant Intravitreal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
82958-501-01
Package Description:
1 CAPSULE in 1 CONTAINER / 1 IMPLANT in 1 CAPSULE
Product Code:
82958-501
Proprietary Name:
Encelto
Non-Proprietary Name:
Revakinagene Taroretcel-lwey
Substance Name:
Revakinagene Taroretcel
Usage Information:
ENCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).
11-Digit NDC Billing Format:
82958050101
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Neurotech Pharmaceuticals, Inc.
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(s):
Intravitreal - Administration within the vitreous body of the eye.
Active Ingredient(s):
REVAKINAGENE TARORETCEL 440000 [arb'U]/1
Sample Package:
No
FDA Application Number:
BLA125798
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
03-12-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 82958-501-01?

The NDC Packaged Code 82958-501-01 is assigned to a package of 1 capsule in 1 container / 1 implant in 1 capsule of Encelto, a human prescription drug labeled by Neurotech Pharmaceuticals, Inc.. The product's dosage form is implant and is administered via intravitreal form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

Is NDC 82958-501 included in the NDC Directory?

Yes, Encelto with product code 82958-501 is active and included in the NDC Directory. The product was first marketed by Neurotech Pharmaceuticals, Inc. on March 12, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 82958-501-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

What is the 11-digit format for NDC 82958-501-01?

The 11-digit format is 82958050101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-282958-501-015-4-282958-0501-01