Home NDC 52856-601 KEBILIDI
Product NDC 52856-601
11-digit product format 528560601
Labeler code 52856
Product ID 52856-601_82f12b65-d2a0-450a-9f11-49ce8aad2e27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eladocagene exuparvovec-tneq
Dosage form SUSPENSION
Route INTRACEREBRAL
Labeler PTC Therapeutics, Inc.
Application BLA125722
Marketing category BLA
Marketing start 2024-11-13
Substance ELADOCAGENE EXUPARVOVEC
Active strength 560000000000 {GC}/mL
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 KEBILIDI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELADOCAGENE EXUPARVOVEC 560000000000 {GC}/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S51J6N56M7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2698771 Internal RxNorm lookup 2698778 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52856-601-01 KEBILIDI 1 in 1 CARTON SUSPENSION 1 3 52856-601-11 KEBILIDI 0.5 mL in 1 VIAL, GLASS SUSPENSION 0.5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52856-601 KEBILIDI (ELADOCAGENE EXUPARVOVEC-TNEQ) SUSPENSION [PTC THERAPEUTICS, INC.] 2 Current NDC, 2 package rows 20241204_9d6a6401-c6b5-4f29-af11-67707d249482.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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125722 KEBILIDI eladocagene exuparvovec-tneq 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2698771 eladocagene exuparvovec-tneq 560,000,000,000 VECTOR-GENOMES in 0.5 ML Injection PSN 9d6a6401-c6b5-4f29-af11-67707d249482 3 2698778 Kebilidi 560,000,000,000 VECTOR-GENOMES in 0.5 ML Injection PSN 9d6a6401-c6b5-4f29-af11-67707d249482 3 2698778 0.5 ML eladocagene exuparvovec-tneq 560000000000 VECTOR-GENOMES/ML Injection [Kebilidi] SBD 9d6a6401-c6b5-4f29-af11-67707d249482 3 2698771 0.5 ML eladocagene exuparvovec-tneq 560000000000 VECTOR-GENOMES/ML Injection SCD 9d6a6401-c6b5-4f29-af11-67707d249482 3 2698778 0.5 ML Kebilidi 560000000000 VECTOR-GENOMES/ML Injection SY 9d6a6401-c6b5-4f29-af11-67707d249482 3 2698771 eladocagene exuparvovec-tneq 560,000,000,000 VECTOR-GENOMES per 0.5 ML Injection SY 9d6a6401-c6b5-4f29-af11-67707d249482 3 2698778 Kebilidi 560,000,000,000 VECTOR-GENOMES per 0.5 ML Injection SY 9d6a6401-c6b5-4f29-af11-67707d249482 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 52856-601-01 52856060101 1 VIAL, GLASS in 1 CARTON (52856-601-01) / .5 mL in 1 VIAL, GLASS (52856-601-11) 2024-11-13 No No Current 52856-601-11 52856060111 0.5 mL in 1 VIAL, GLASS 0.5 ml Historical