FDA.reportPublic FDA data

Leukine

Product NDC
0024-5844
11-digit product format
000245844
Labeler code
0024
Product ID
0024-5844_ac281296-b49b-4f33-a16c-a83e60964713
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SARGRAMOSTIM
Dosage form
LIQUID
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
sanofi-aventis U.S. LLC
Application
BLA103362
Marketing category
BLA
Marketing start
1996-12-01
Marketing end
2021-12-30
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
0000-00-00
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.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0024-5844DDiscontinued by firm2026-07-31
excluded packagepackage0024-58440024-5844-01DDiscontinued by firm2026-07-31
excluded packagepackage0024-58440024-5844-05DDiscontinued by firm2026-07-31

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.

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SARGRAMOSTIMACTIVE INGREDIENT5TAA004E22LEUKINE (SARGRAMOSTIM) LIQUID LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC]4
sargramostimACTIVE MOIETY5TAA004E22LEUKINE (SARGRAMOSTIM) LIQUID LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLEUKINE (SARGRAMOSTIM) LIQUID LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ALEUKINE (SARGRAMOSTIM) LIQUID LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC]4
SUCROSEINACTIVE INGREDIENTC151H8M554LEUKINE (SARGRAMOSTIM) LIQUID LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC]4
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VLEUKINE (SARGRAMOSTIM) LIQUID LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC]4

Purple Book Biologic Products#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0024-5844-01000245844011 VIAL, MULTI-DOSE in 1 CARTON (0024-5844-01) > 1 mL in 1 VIAL, MULTI-DOSE1996-12-012021-12-30NoNoCurrent
0024-5844-05000245844055 VIAL in 1 CARTON (0024-5844-05) > 1 mL in 1 VIAL5 vial1996-12-012021-12-30NoNoCurrent