FDA.reportPublic FDA data

NDC 83222-0200-01 - LENMELDY

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
83222-0200
Requested NDC
83222-0200-01
Package NDCs from labels
83222-0200-1, 83222-0200-01
Manufacturer
Orchard Therapeutics (Europe) Ltd | AGC Biologics SPA
Effective date
2026-10-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LENMELDY - Orchard Therapeutics (Europe) Ltd | AGC Biologics SPAOrchard Therapeutics (Europe) Ltd | AGC Biologics SPA2026-10-01CELLULAR THERAPY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83222-0200-1LENMELDY1 in 1 BAGSUSPENSION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83222-0200LENMELDY (ATIDARSAGENE AUTOTEMCEL) SUSPENSION [ORCHARD THERAPEUTICS (EUROPE) LTD]5Current NDC, 1 package rows20240426_b3e307a7-561b-43b6-a784-9cb1dcfc5196.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83222-0200-1EA - Each83222-020057fdf7ff-d690-45dc-8717-bf021ff2890612024-04-05

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 ยท 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dimethyl SulfoxideDIMETHYL SULFOXIDERenova Pharmaceuticals LLC8f699de6-9d09-48da-9d95-4001d70085872026-07-20Warnings, Adverse reactionsExact identifier
unii: YOW8V9698H
LENMELDYATIDARSAGENE AUTOTEMCELOrchard Therapeutics (Europe) Ltdb3e307a7-561b-43b6-a784-9cb1dcfc51962026-06-17Warnings, Adverse reactionsExact identifier
application number: BLA125758
ndc (package): 83222-0200-1
ndc (product): 83222-0200
ndc11 (package): 83222020001
rxcui: 2677920
rxcui: 2677926
spl id: 5474a8af-7dd9-3e6a-e063-6294a90a8de2
spl set id: b3e307a7-561b-43b6-a784-9cb1dcfc5196
unii: EPP8G99QG4
Proteinuria Drops 2053PROTEINURIA DROPSProfessional Complementary Health Formulas1bf80282-8283-4835-acd4-fbdb47788c672026-01-08WarningsExact identifier
unii: ZIF514RVZR
Shusher CareISOTONIC SODIUM CHLORIDEpNeo LLC1bac18ca-5446-4ca7-9e2f-42d701c8cf462025-04-01WarningsExact identifier
unii: VR5Y7PDT5W
ALBUMINEXALBUMIN HUMANBPL8428d373-f4b1-4e3b-bb19-ea89048f7c792024-12-31Warnings, Adverse reactionsExact identifier
unii: ZIF514RVZR
ALBUMINEXALBUMIN HUMANBPL167f48d0-8ae5-4f7e-b050-9673dad78acc2024-12-31Warnings, Adverse reactionsExact identifier
unii: ZIF514RVZR
RIMSO-50DIMETHYL SULFOXIDEMylan Institutional LLC58b25d79-78f2-4953-b0c6-61658dc4ef0d2021-03-17Warnings, Adverse reactionsExact identifier
unii: YOW8V9698H

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.