Home NDC 73776-022 PROLEUKIN
Product NDC 73776-022
11-digit product format 737760022
Labeler code 73776
Product ID 73776-022_29ba86b1-f672-482e-e063-6394a90a931f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name aldesleukin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Iovance Biotherapeutics, Inc
Application BLA103293
Marketing category BLA
Marketing start 1992-05-05
Substance ALDESLEUKIN
Active strength 1.1 mg/mL
Pharmacologic classes Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base PROLEUKIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALDESLEUKIN 1.1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M89N0Q7EQR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 105648 Internal RxNorm lookup 307816 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73776-022-01 PROLEUKIN 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 7 73776-022-01 PROLEUKIN 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73776-022 PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [IOVANCE BIOTHERAPEUTICS, INC] 7 Current NDC, 2 package rows 20241222_f3c516ad-d405-4fbe-af6a-962080dbfa7d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103293 Proleukin aldesleukin 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 73776-022-01 73776002201 1 VIAL, SINGLE-DOSE in 1 CARTON (73776-022-01) / 1 mL in 1 VIAL, SINGLE-DOSE 2024-07-15 No No Current