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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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 2026-06-01
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