Home NDC 83222-0200 LENMELDY
Product NDC 83222-0200
11-digit product format 832220200
Labeler code 83222
Product ID 83222-0200_5cd8c620-51bc-9939-e063-6294a90a6445
Type CELLULAR THERAPY
Nonproprietary name atidarsagene autotemcel
Dosage form SUSPENSION
Route INTRAVENOUS
Labeler Orchard Therapeutics (Europe) Ltd
Application BLA125758
Marketing category BLA
Marketing start 2024-04-26
Substance ATIDARSAGENE AUTOTEMCEL
Active strength 11800000 1/1
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 LENMELDY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATIDARSAGENE AUTOTEMCEL 11800000 1/1
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83222-0200-1 LENMELDY 1 in 1 BAG SUSPENSION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83222-0200 LENMELDY (ATIDARSAGENE AUTOTEMCEL) SUSPENSION [ORCHARD THERAPEUTICS (EUROPE) LTD] 5 Current NDC, 1 package rows 20240426_b3e307a7-561b-43b6-a784-9cb1dcfc5196.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 LENMELDY ATIDARSAGENE AUTOTEMCEL Orchard Therapeutics (Europe) Ltd b3e307a7-561b-43b6-a784-9cb1dcfc5196 2026-06-17 Warnings, Adverse reactions Exact identifier application number: BLA125758 ndc (product): 83222-0200
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125758 Lenmeldy atidarsagene autotemcel 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2677920 atidarsagene autotemcel 11,800,000 CELLS/ML in 10 ML Injection PSN b3e307a7-561b-43b6-a784-9cb1dcfc5196 7 2677926 lenmeldy 11,800,000 CELLS/ML in 10 ML Injection PSN b3e307a7-561b-43b6-a784-9cb1dcfc5196 7 2677926 10 ML atidarsagene autotemcel 11800000 CELLS/ML Injection [Lenmeldy] SBD b3e307a7-561b-43b6-a784-9cb1dcfc5196 7 2677920 10 ML atidarsagene autotemcel 11800000 CELLS/ML Injection SCD b3e307a7-561b-43b6-a784-9cb1dcfc5196 7 2677920 atidarsagene autotemcel 11,800,000 CELLS/ML per 10 ML Injection SY b3e307a7-561b-43b6-a784-9cb1dcfc5196 7 2677926 Lenmeldy 11,800,000 CELLS/ML per 10 ML Injection SY b3e307a7-561b-43b6-a784-9cb1dcfc5196 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83222-0200-1 83222020001 1 SUSPENSION in 1 BAG (83222-0200-1) 1 suspension 2024-04-26 No No Current