Home NDC 81481-803-01 ANKTIVA
Product NDC 81481-803
Requested package NDC 81481-803-01
11-digit product format 814810803
Labeler code 81481
Product ID 81481-803_5ed7fe40-a69b-0d42-e063-6394a90a7f64
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nogapendekin alfa inbakicept-pmln
Dosage form SOLUTION
Route INTRAVESICAL
Labeler Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.
Application BLA761336
Marketing category BLA
Marketing start 2024-05-06
Substance NOGAPENDEKIN ALFA INBAKICEPT-PMLN
Active strength 400 ug/.4mL
Pharmacologic classes Interleukin-15 Receptor Agonist [EPC], Interleukin-15 Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ANKTIVA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NOGAPENDEKIN ALFA INBAKICEPT-PMLN 400 ug/.4mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81481-803-01 ANKTIVA 1 in 1 BOX SOLUTION 1 9 81481-803-01 ANKTIVA 0.4 mL in 1 VIAL, GLASS SOLUTION 0.4 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81481-803 ANKTIVA (NOGAPENDEKIN ALFA INBAKICEPT-PMLN) SOLUTION [ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SUBSIDIARY OF IMMUNITYBIO, INC.] 5 Current NDC, 2 package rows 20240511_eae31db8-3e7a-d9e0-708d-74419d1b50ff.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ANKTIVA NOGAPENDEKIN ALFA INBAKICEPT-PMLN Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc. eae31db8-3e7a-d9e0-708d-74419d1b50ff 2025-06-24 Warnings, Adverse reactions Exact identifier application number: BLA761336 ndc (package): 81481-803-01 ndc (product): 81481-803 ndc11 (package): 81481080301
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761336 Anktiva nogapendekin alfa inbakicept-pmln 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 81481-803-01 81481080301 1 VIAL, GLASS in 1 BOX (81481-803-01) / .4 mL in 1 VIAL, GLASS 2024-05-06 No No Current