FDA.reportPublic FDA data

sargramostim 0.25 MG/ML Injectable Solution [Leukine]

RxCUI
208083
RxNorm name
sargramostim 0.25 MG/ML Injectable Solution [Leukine]
Display name
sargramostim 0.25 MG/ML Injectable Solution [Leukine]
Full name
sargramostim 0.25 MG/ML Injectable Solution [Leukine]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:18

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103362Leukinesargramostim351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LeukineSARGRAMOSTIMPartner Therapeutics, Inc.bb9a3820-f31a-4dd9-bef4-97094c01a3982024-12-06Warnings, Adverse reactionsExact identifier
rxcui: 208083

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
bb9a3820-f31a-4dd9-bef4-97094c01a398sargramostim 0.25 MG/ML Injectable Solution [Leukine]SBD8These highlights do not include all the information needed to use LEUKINE safely and effectively. See full prescribing information for LEUKINE. LEUKINE ® (sargramostim) for injection, for subcutaneous or intravenous use Initial U.S. Approval: 199120241206
bb9a3820-f31a-4dd9-bef4-97094c01a398Leukine 250 MCG/ML Injectable SolutionSY8These highlights do not include all the information needed to use LEUKINE safely and effectively. See full prescribing information for LEUKINE. LEUKINE ® (sargramostim) for injection, for subcutaneous or intravenous use Initial U.S. Approval: 199120241206
bb9a3820-f31a-4dd9-bef4-97094c01a398Leukine 250 MCG/ML Injectable SolutionPSN8These highlights do not include all the information needed to use LEUKINE safely and effectively. See full prescribing information for LEUKINE. LEUKINE ® (sargramostim) for injection, for subcutaneous or intravenous use Initial U.S. Approval: 199120241206
bb9a3820-f31a-4dd9-bef4-97094c01a398Leukine 0.25 MG/ML Injectable SolutionSY8These highlights do not include all the information needed to use LEUKINE safely and effectively. See full prescribing information for LEUKINE. LEUKINE ® (sargramostim) for injection, for subcutaneous or intravenous use Initial U.S. Approval: 199120241206