NDC 71837-5843

Leukine

Sargramostim

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

• Product ID: 71837-5843_178cab59-44ed-48f8-bd43-40da496962ff
• NDC: 71837-5843
• Product Type: Human Prescription Drug
• Proprietary Name: Leukine
• Generic Name: Sargramostim
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 1991-03-05
• Marketing Category: BLA / BLA
• Application Number: BLA103362
• Labeler Name: Partner Therapeutics, Inc
• Substance Name: SARGRAMOSTIM
• Active Ingredient Strength: 250 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: 2023-12-31

Packaging

NDC 71837-5843-5

5 VIAL, SINGLE-DOSE in 1 CARTON (71837-5843-5) > 1 mL in 1 VIAL, SINGLE-DOSE (71837-5843-1)

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

NDC SPL Data Element Entries

NDC 71837-5843-1 [71837584301]

Leukine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103362
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-07

NDC 71837-5843-5 [71837584305]

Leukine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103362
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-05-30

Drug Details

Active Ingredients

Ingredient	Strength
SARGRAMOSTIM	250 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