proleukin

Generic: aldesleukin

Labeler: iovance biotherapeutics, inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name proleukin
Generic Name aldesleukin
Labeler iovance biotherapeutics, inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

aldesleukin 1.1 mg/mL

Manufacturer
Iovance Biotherapeutics, Inc

Identifiers & Regulatory

Product NDC 73776-022
Product ID 73776-022_29ba86b1-f672-482e-e063-6394a90a931f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103293
Listing Expiration 2026-12-31
Marketing Start 1992-05-05

Pharmacologic Class

Established (EPC)
lymphocyte growth factor [epc]
Chemical Structure
interleukin-2 [cs]
Physiologic Effect
increased lymphocyte activation [pe] increased lymphocyte cell production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 73776022
Hyphenated Format 73776-022

Supplemental Identifiers

RxCUI
105648 307816
UNII
M89N0Q7EQR
NUI
N0000178328 N0000009391 M0011506 N0000175667

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name proleukin (source: ndc)
Generic Name aldesleukin (source: ndc)
Application Number BLA103293 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1.1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (73776-022-01) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

73776-022-01 1 VIAL, SINGLE-DOSE in 1 CARTON (73776-022-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

aldesleukin (1.1 mg/mL)

Linked Drug Pages (1)

PROLEUKIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "29ba86b1-f672-482e-e063-6394a90a931f", "openfda": {"nui": ["N0000178328", "N0000009391", "M0011506", "N0000175667"], "unii": ["M89N0Q7EQR"], "rxcui": ["105648", "307816"], "spl_set_id": ["f3c516ad-d405-4fbe-af6a-962080dbfa7d"], "pharm_class_cs": ["Interleukin-2 [CS]"], "pharm_class_pe": ["Increased Lymphocyte Activation [PE]", "Increased Lymphocyte Cell Production [PE]"], "pharm_class_epc": ["Lymphocyte Growth Factor [EPC]"], "manufacturer_name": ["Iovance Biotherapeutics, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (73776-022-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "73776-022-01", "marketing_start_date": "20240715"}], "brand_name": "PROLEUKIN", "product_id": "73776-022_29ba86b1-f672-482e-e063-6394a90a931f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Increased Lymphocyte Activation [PE]", "Increased Lymphocyte Cell Production [PE]", "Interleukin-2 [CS]", "Lymphocyte Growth Factor [EPC]"], "product_ndc": "73776-022", "generic_name": "aldesleukin", "labeler_name": "Iovance Biotherapeutics, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROLEUKIN", "active_ingredients": [{"name": "ALDESLEUKIN", "strength": "1.1 mg/mL"}], "application_number": "BLA103293", "marketing_category": "BLA", "marketing_start_date": "19920505", "listing_expiration_date": "20261231"}