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

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

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

Purple Book Biologic Products#

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

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