PROLEUKIN
- Product NDC
- 73776-022
- 11-digit product format
- 737760022
- Labeler code
- 73776
- Product ID
- 73776-022_29ba86b1-f672-482e-e063-6394a90a931f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- aldesleukin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Iovance Biotherapeutics, Inc
- Application
- BLA103293
- Marketing category
- BLA
- Marketing start
- 1992-05-05
- Substance
- ALDESLEUKIN
- Active strength
- 1.1 mg/mL
- Pharmacologic classes
- Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PROLEUKIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALDESLEUKIN | 1.1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M89N0Q7EQR |
| Rxcui | 105648, 307816 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73776-022-01 | PROLEUKIN | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
| 73776-022-01 | PROLEUKIN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73776-022 | PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [IOVANCE BIOTHERAPEUTICS, INC] | 7 | Current NDC, 2 package rows | 20241222_f3c516ad-d405-4fbe-af6a-962080dbfa7d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 73776-022-01 | 73776002201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (73776-022-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2024-07-15 | No | No | Current |