NDC 65483-116

Proleukin

Aldesleukin

Proleukin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Prometheus Laboratories Inc.. The primary component is Aldesleukin.

• Product ID: 65483-116_19ecd363-f6c8-4cb0-ab25-2ee9784f8582
• NDC: 65483-116
• Product Type: Human Prescription Drug
• Proprietary Name: Proleukin
• Generic Name: Aldesleukin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1992-05-05
• Marketing Category: BLA / BLA
• Application Number: BLA103293
• Labeler Name: Prometheus Laboratories Inc.
• Substance Name: ALDESLEUKIN
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Increased Lymphocyte Activation [PE],Increased Lymphocyte Cell Production [PE],Interleukin-2 [CS],Lymphocyte Growth Factor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 65483-116-07

1 VIAL, SINGLE-USE in 1 CARTON (65483-116-07) > 1 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 1992-05-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65483-116-07 [65483011607]

Proleukin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103293
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1992-05-05

Drug Details

Active Ingredients

Ingredient	Strength
ALDESLEUKIN	1.1 mg/mL

OpenFDA Data

• SPL SET ID: 4e2b687e-47f2-4f3c-80ab-e3224befffca
• Manufacturer:
  • Prometheus Laboratories Inc.
• UNII:
  • M89N0Q7EQR
• RxNorm Concept Unique ID - RxCUI:
  • 105648
  • 307816
• UPC Code:
  • 0365483116076

Pharmacological Class

• Increased Lymphocyte Activation [PE]
• Increased Lymphocyte Cell Production [PE]
• Interleukin-2 [CS]
• Lymphocyte Growth Factor [EPC]

NDC Crossover Matching brand name "Proleukin" or generic name "Aldesleukin"

NDC	Brand Name	Generic Name
65483-116	Proleukin	aldesleukin
76310-022	Proleukin	aldesleukin
17089-380	GUNA-IL 2	ALDESLEUKIN