FDA.reportPublic FDA data

LENMELDY

Product NDC
83222-0200
11-digit product format
832220200
Labeler code
83222
Product ID
83222-0200_3c2e8ac2-b01d-d709-e063-6294a90a24da
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
2026-12-31
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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LENMELDYATIDARSAGENE AUTOTEMCELOrchard Therapeutics (Europe) Ltdb3e307a7-561b-43b6-a784-9cb1dcfc51962026-06-17Warnings, Adverse reactionsExact identifier
application number: BLA125758
ndc (product): 83222-0200

Additional Listing Data#

Finished product
Yes
Brand name base
LENMELDY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATIDARSAGENE AUTOTEMCEL11800000 1/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EPP8G99QG4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2677920Internal RxNorm lookup
2677926Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b3e307a7-561b-43b6-a784-9cb1dcfc5196Available on FDA.report

DailyMed Package Descriptions#

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

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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125758Lenmeldyatidarsagene autotemcel351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2677920atidarsagene autotemcel 11,800,000 CELLS/ML in 10 ML InjectionPSNb3e307a7-561b-43b6-a784-9cb1dcfc51967
2677926lenmeldy 11,800,000 CELLS/ML in 10 ML InjectionPSNb3e307a7-561b-43b6-a784-9cb1dcfc51967
267792610 ML atidarsagene autotemcel 11800000 CELLS/ML Injection [Lenmeldy]SBDb3e307a7-561b-43b6-a784-9cb1dcfc51967
267792010 ML atidarsagene autotemcel 11800000 CELLS/ML InjectionSCDb3e307a7-561b-43b6-a784-9cb1dcfc51967
2677920atidarsagene autotemcel 11,800,000 CELLS/ML per 10 ML InjectionSYb3e307a7-561b-43b6-a784-9cb1dcfc51967
2677926Lenmeldy 11,800,000 CELLS/ML per 10 ML InjectionSYb3e307a7-561b-43b6-a784-9cb1dcfc51967

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83222-0200-1832220200011 SUSPENSION in 1 BAG (83222-0200-1) 1 suspension2024-04-26NoNoCurrent