Proleukin
- Product NDC
- 65483-116
- 11-digit product format
- 654830116
- Labeler code
- 65483
- Product ID
- 65483-116_b50616d7-928a-4c4b-96fe-b17d0fcc52c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- aldesleukin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Prometheus Laboratories Inc.
- Application
- BLA103293
- Marketing category
- BLA
- Marketing start
- 1992-05-05
- Marketing end
- 0000-00-00
- Substance
- ALDESLEUKIN
- Active strength
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65483-116-07 | Proleukin | 1 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 15 |
| 65483-116-07 | Proleukin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| aldesleukin | ACTIVE INGREDIENT | M89N0Q7EQR | PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.] | 13 | |
| aldesleukin | ACTIVE MOIETY | M89N0Q7EQR | PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.] | 13 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.] | 13 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.] | 13 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.] | 13 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.] | 13 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65483-116 | PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.] | 15 | Legacy NDC, 2 package rows | 20190607_4e2b687e-47f2-4f3c-80ab-e3224befffca.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 65483-116-07 | 65483011607 | 1 mL in 1 VIAL, SINGLE-USE | 1 ml | Historical |