Leukine
- Product NDC
- 71837-5844
- 11-digit product format
- 718375844
- Labeler code
- 71837
- Product ID
- 71837-5844_c759164c-4423-40a6-8f60-2f56ab72ee31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SARGRAMOSTIM
- Dosage form
- LIQUID
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Partner Therapeutics, Inc
- Application
- BLA103362
- Marketing category
- BLA
- Marketing start
- 2018-05-30
- Marketing end
- 0000-00-00
- Substance
- SARGRAMOSTIM
- Active strength
- 500 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 71837-5844 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 71837-5844 | 71837-5844-1 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 71837-5844 | 71837-5844-5 | D | Discontinued by firm | 2026-07-31 |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Leukine | SARGRAMOSTIM | Partner Therapeutics, Inc. | bb9a3820-f31a-4dd9-bef4-97094c01a398 | 2024-12-06 | Warnings, Adverse reactions | BLA103362 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103362 | Leukine | sargramostim | 351(a) | Rx | 2026-06-01 |