NDC 76310-022

Proleukin

Aldesleukin

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

• Product ID: 76310-022_3b04162e-e9f0-4fea-9dc0-62a9ebd6ef9e
• NDC: 76310-022
• 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: Clinigen Group PLC
• 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: 2020-12-31

Packaging

NDC 76310-022-01

1 VIAL, SINGLE-DOSE in 1 CARTON (76310-022-01) > 1 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-12-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76310-022-01 [76310002201]

Proleukin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103293
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-12-31

Drug Details

Active Ingredients

Ingredient	Strength
ALDESLEUKIN	1.1 mg/mL

OpenFDA Data

• SPL SET ID: deead498-9f19-48cf-87c7-6caf2263f2ab
• Manufacturer:
  • Clinigen Group PLC
• UNII:
  • M89N0Q7EQR
• RxNorm Concept Unique ID - RxCUI:
  • 105648
  • 307816

Pharmacological Class

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