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 |
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 | 2026-10-01 |
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 |