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)Rx2026-09-01

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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
bb9a3820-f31a-4dd9-bef4-97094c01a398Leukine 250 MCG/ML Injectable Solution [PSN] · sargramostim 0.25 MG/ML Injectable Solution [Leukine] [SBD] · Leukine 0.25 MG/ML Injectable Solution [SY] · Leukine 250 MCG/ML Injectable Solution [SY]48These 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