NDC 0024-5844

Leukine

Sargramostim

Leukine is a Intravenous; Subcutaneous Liquid in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Sargramostim.

Product ID0024-5844_ac281296-b49b-4f33-a16c-a83e60964713
NDC0024-5844
Product TypeHuman Prescription Drug
Proprietary NameLeukine
Generic NameSargramostim
Dosage FormLiquid
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date1996-12-01
Marketing End Date2021-12-30
Marketing CategoryBLA / BLA
Application NumberBLA103362
Labeler Namesanofi-aventis U.S. LLC
Substance NameSARGRAMOSTIM
Active Ingredient Strength500 ug/mL
Pharm ClassesGranulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]
NDC Exclude FlagN

Packaging

NDC 0024-5844-01

1 VIAL, MULTI-DOSE in 1 CARTON (0024-5844-01) > 1 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date1996-12-01
Marketing End Date2021-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0024-5844-05 [00024584405]

Leukine LIQUID
Marketing CategoryBLA
Application NumberBLA103362
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-12-01
Marketing End Date2021-12-30

NDC 0024-5844-01 [00024584401]

Leukine LIQUID
Marketing CategoryBLA
Application NumberBLA103362
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-12-01
Marketing End Date2021-12-30

Drug Details

Active Ingredients

IngredientStrength
SARGRAMOSTIM500 ug/mL

OpenFDA Data

SPL SET ID:04765fbf-f005-43aa-a628-5cc3d80f91e7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312903
  • 208083
  • 213395
  • 315199
  • Pharmacological Class

    • Granulocyte Colony-Stimulating Factor [CS]
    • Granulocyte-Macrophage Colony-Stimulating Factor [CS]
    • Increased Myeloid Cell Production [PE]
    • Leukocyte Growth Factor [EPC]
    • Granulocyte Colony-Stimulating Factor [CS]
    • Granulocyte-Macrophage Colony-Stimulating Factor [CS]
    • Increased Myeloid Cell Production [PE]
    • Leukocyte Growth Factor [EPC]

    NDC Crossover Matching brand name "Leukine" or generic name "Sargramostim"

    NDCBrand NameGeneric Name
    0024-5843LeukineSARGRAMOSTIM
    0024-5844LeukineSARGRAMOSTIM
    71837-5843LeukineSARGRAMOSTIM
    71837-5844LeukineSARGRAMOSTIM

    Trademark Results [Leukine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LEUKINE
    LEUKINE
    73831918 1653426 Live/Registered
    IMMUNEX CORPORATION
    1989-10-13

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.