Leukine
- Product NDC
- 71837-5843
- 11-digit product format
- 718375843
- Labeler code
- 71837
- Product ID
- 71837-5843_4ad3993c-6c7f-4a33-8ead-a912636ff4a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SARGRAMOSTIM
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Partner Therapeutics, Inc.
- Application
- BLA103362
- Marketing category
- BLA
- Marketing start
- 2023-09-01
- Substance
- SARGRAMOSTIM
- Active strength
- 250 ug/mL
- Pharmacologic classes
- Granulocyte Colony-Stimulating Factor [CS], Granulocyte-Macrophage Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte 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
- Leukine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SARGRAMOSTIM | 250 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5TAA004E22 |
| Rxcui | 208083, 315199 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71837-5843-1 | Leukine | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
| 71837-5843-5 | Leukine | 5 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 5 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71837-5843 | LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PARTNER THERAPEUTICS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241212_bb9a3820-f31a-4dd9-bef4-97094c01a398.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71837-5843-1 | 71837584301 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 71837-5843-5 | 71837584305 | 5 VIAL, SINGLE-DOSE in 1 CARTON (71837-5843-5) / 1 mL in 1 VIAL, SINGLE-DOSE (71837-5843-1) | | 2023-09-01 | 0000-00-00 | No | No | Current |