FDA.reportPublic FDA data

Proleukin

Product NDC
76310-022
Requested package NDC
76310-022-01
11-digit product format
763100022
Labeler code
76310
Product ID
76310-022_68da1212-9acf-426a-b3f1-2d20113d7d4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aldesleukin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Clinigen Limited
Application
BLA103293
Marketing category
BLA
Marketing start
1992-05-05
Marketing end
0000-00-00
Substance
ALDESLEUKIN
Active strength
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76310-02276310-022-01DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROLEUKINALDESLEUKINIovance Biotherapeutics, Incf3c516ad-d405-4fbe-af6a-962080dbfa7d2024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103293

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76310-022-01EA - Each76310-022954b9e7e-3df5-4982-864d-d35a21ee105b12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76310-022PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CLINIGEN LIMITED]7Legacy NDC20240622_deead498-9f19-48cf-87c7-6caf2263f2ab.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103293Proleukinaldesleukin351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76310-022-01763100022011 VIAL, SINGLE-DOSE in 1 CARTON (76310-022-01) > 1 mL in 1 VIAL, SINGLE-DOSE2019-12-310000-00-00NoNoCurrent