Home NDC 82958-501 ENCELTO
Product NDC 82958-501
11-digit product format 829580501
Labeler code 82958
Product ID 82958-501_943731b7-6b10-4527-ac10-53a5a5e3a5ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name revakinagene taroretcel-lwey
Dosage form IMPLANT
Route INTRAVITREAL
Labeler Neurotech Pharmaceuticals, Inc.
Application BLA125798
Marketing category BLA
Marketing start 2025-03-12
Substance REVAKINAGENE TARORETCEL-LWEY
Active strength 440000 [arb'U]/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ENCELTO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength REVAKINAGENE TARORETCEL-LWEY 440000 [arb'U]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q7V7NYG6GM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2708837 Internal RxNorm lookup 2708843 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82958-501-01 ENCELTO 1 in 1 CAPSULE IMPLANT 1 2 82958-501-01 ENCELTO 1 in 1 CONTAINER IMPLANT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82958-501 ENCELTO (REVAKINAGENE TARORETCEL-LWEY) IMPLANT [NEUROTECH PHARMACEUTICALS, INC.] 2 Current NDC, 2 package rows 20250326_1ae9482a-b478-4e21-9166-b5fd52d3ef9c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ENCELTO REVAKINAGENE TARORETCEL-LWEY Neurotech Pharmaceuticals, Inc. 1ae9482a-b478-4e21-9166-b5fd52d3ef9c 2026-08-26 Warnings, Adverse reactions Exact identifier application number: BLA125798 ndc (product): 82958-501
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125798 encelto revakinagene taroretcel-lwey 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2708843 ENCELTO 200,000 to 440,000 CELLS Intravitreal Implant PSN 1ae9482a-b478-4e21-9166-b5fd52d3ef9c 2 2708837 revakinagene taroretcel-lwey 200,000 to 440,000 CELLS Intravitreal Implant PSN 1ae9482a-b478-4e21-9166-b5fd52d3ef9c 2 2708843 revakinagene taroretcel-lwey 440000 CELLS Drug Implant [Encelto] SBD 1ae9482a-b478-4e21-9166-b5fd52d3ef9c 2 2708837 revakinagene taroretcel-lwey 440000 CELLS Drug Implant SCD 1ae9482a-b478-4e21-9166-b5fd52d3ef9c 2 2708843 Encelto 200,000 to 440,000 CELLS Intravitreal Implant SY 1ae9482a-b478-4e21-9166-b5fd52d3ef9c 2 2708837 revakinagene taroretcel-lwey 200,000 to 440,000 CELLS Intravitreal Implant SY 1ae9482a-b478-4e21-9166-b5fd52d3ef9c 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82958-501-01 82958050101 1 CAPSULE in 1 CONTAINER (82958-501-01) / 1 IMPLANT in 1 CAPSULE 1 capsule 2025-03-12 No No Current