NDC 71837-5844

Leukine

Sargramostim

Leukine is a Intravenous; Subcutaneous Liquid in the Human Prescription Drug category. It is labeled and distributed by Partner Therapeutics, Inc. The primary component is Sargramostim.

• Product ID: 71837-5844_c759164c-4423-40a6-8f60-2f56ab72ee31
• NDC: 71837-5844
• Product Type: Human Prescription Drug
• Proprietary Name: Leukine
• Generic Name: Sargramostim
• Dosage Form: Liquid
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2018-05-30
• Marketing Category: BLA / BLA
• Application Number: BLA103362
• Labeler Name: Partner Therapeutics, Inc
• Substance Name: SARGRAMOSTIM
• Active Ingredient Strength: 500 ug/mL
• Pharm Classes: Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71837-5844-1

1 VIAL, MULTI-DOSE in 1 CARTON (71837-5844-1) > 1 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2018-05-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71837-5844-5 [71837584405]

Leukine INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103362
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1991-03-05
• Marketing End Date: 2012-05-08

NDC 71837-5844-1 [71837584401]

Leukine INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103362
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1991-03-05
• Marketing End Date: 2012-05-08

Drug Details

Active Ingredients

Ingredient	Strength
SARGRAMOSTIM	500 ug/mL

OpenFDA Data

• SPL SET ID: bb9a3820-f31a-4dd9-bef4-97094c01a398
• Manufacturer:
  • Partner Therapeutics, Inc
• UNII:
  • 5TAA004E22
• 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]

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

NDC	Brand Name	Generic Name
0024-5843	Leukine	SARGRAMOSTIM
0024-5844	Leukine	SARGRAMOSTIM
71837-5843	Leukine	SARGRAMOSTIM
71837-5844	Leukine	SARGRAMOSTIM