Proleukin

Product NDC
76310-022
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

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

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