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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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 firm2026-08-17

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

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.

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103293Proleukinaldesleukin351(a)Rx2026-07-01

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