FDA.reportPublic FDA data

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

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Leukine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SARGRAMOSTIM250 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TAA004E22Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
208083Internal RxNorm lookup
315199Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb9a3820-f31a-4dd9-bef4-97094c01a398Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
8e3a51c8-5e17-4957-af5e-12bb8b4f6470Product name120180611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71837-5843-1Leukine1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,18
71837-5843-5Leukine5 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71837-5843-1EA - Each71837-5843cdf0bfd0-fcf1-43ea-aeae-95a6c803032812021-01-08
71837-5843-5EA - Each71837-58439a89547b-f4af-4f33-a647-a71b94e8dbe312021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71837-5843LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PARTNER THERAPEUTICS, INC.]8Current NDC, Legacy NDC, 2 package rows20241212_bb9a3820-f31a-4dd9-bef4-97094c01a398.zip

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
application number: BLA103362
ndc (product): 71837-5843

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103362Leukinesargramostim351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208083Leukine 250 MCG/ML Injectable SolutionPSNbb9a3820-f31a-4dd9-bef4-97094c01a3988
315199sargramostim 250 MCG/ML Injectable SolutionPSNbb9a3820-f31a-4dd9-bef4-97094c01a3988
208083sargramostim 0.25 MG/ML Injectable Solution [Leukine]SBDbb9a3820-f31a-4dd9-bef4-97094c01a3988
315199sargramostim 0.25 MG/ML Injectable SolutionSCDbb9a3820-f31a-4dd9-bef4-97094c01a3988
208083Leukine 0.25 MG/ML Injectable SolutionSYbb9a3820-f31a-4dd9-bef4-97094c01a3988
208083Leukine 250 MCG/ML Injectable SolutionSYbb9a3820-f31a-4dd9-bef4-97094c01a3988
315199sargramostim 250 MCG/ML Injectable SolutionSYbb9a3820-f31a-4dd9-bef4-97094c01a3988

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71837-5843-1718375843011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
71837-5843-5718375843055 VIAL, SINGLE-DOSE in 1 CARTON (71837-5843-5) / 1 mL in 1 VIAL, SINGLE-DOSE (71837-5843-1) 2023-09-010000-00-00NoNoCurrent