LANTIDRA
- Product NDC
- 73539-001
- 11-digit product format
- 735390001
- Labeler code
- 73539
- Product ID
- 73539-001_a3163e14-0404-4e27-884b-f6f9f7f695bc
- Type
- CELLULAR THERAPY
- Nonproprietary name
- DONISLECEL
- Dosage form
- SOLUTION
- Route
- INTRAVASCULAR
- Labeler
- CellTrans Inc.
- Application
- BLA125734
- Marketing category
- BLA
- Marketing start
- 2023-06-28
- Substance
- DONISLECEL
- Active strength
- 5000 [arb'U]/400mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LANTIDRA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DONISLECEL | 5000 [arb'U]/400mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FW00DG4E3P |
| Rxcui | 2642264, 2642270 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73539-001-01 | LANTIDRA | 400 mL in 1 BAG | SOLUTION | 400 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73539-001 | LANTIDRA (DONISLECEL) SOLUTION [CELLTRANS INC.] | 2 | Current NDC, 1 package rows | 20241206_24610d9f-0c5a-4f55-93b3-d456300bfd5d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 73539-001-01 | 73539000101 | 400 mL in 1 BAG (73539-001-01) | 400 ml | 2023-06-28 | No | No | Historical |