ANKTIVA

Product NDC
81481-803
11-digit product format
814810803
Labeler code
81481
Product ID
81481-803_3851a6cd-d487-2012-e063-6394a90aa33e
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ANKTIVA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NOGAPENDEKIN ALFA INBAKICEPT-PMLN400 ug/.4mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TK323DLA0
Rxcui2682684, 2682691

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81481-803-01ANKTIVA1 in 1 BOXSOLUTION19
81481-803-01ANKTIVA0.4 mL in 1 VIAL, GLASSSOLUTION0.49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81481-803-01ML - Milliliter81481-803d2096e16-5355-4885-8d5b-92fc8b74f40112024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81481-803ANKTIVA (NOGAPENDEKIN ALFA INBAKICEPT-PMLN) SOLUTION [ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SUBSIDIARY OF IMMUNITYBIO, INC.]5Current NDC, 2 package rows20240511_eae31db8-3e7a-d9e0-708d-74419d1b50ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2682691Anktiva 400 MCG in 0.4 ML Intravesical SolutionPSNeae31db8-3e7a-d9e0-708d-74419d1b50ff9
2682684nogapendekin alfa inbakicept-pmln 400 MCG in 0.4 ML Intravesical SolutionPSNeae31db8-3e7a-d9e0-708d-74419d1b50ff9
26826910.4 ML nogapendekin alfa inbakicept-pmln 1 MG/ML Intravesical Solution [Anktiva]SBDeae31db8-3e7a-d9e0-708d-74419d1b50ff9
26826840.4 ML nogapendekin alfa inbakicept-pmln 1 MG/ML Intravesical SolutionSCDeae31db8-3e7a-d9e0-708d-74419d1b50ff9
26826910.4 ML Anktiva 1 MG/ML Intravesical SolutionSYeae31db8-3e7a-d9e0-708d-74419d1b50ff9
2682691Anktiva 400 MCG per 0.4 ML Intravesical SolutionSYeae31db8-3e7a-d9e0-708d-74419d1b50ff9
2682684nogapendekin alfa inbakicept-pmln 400 MCG per 0.4 ML Intravesical SolutionSYeae31db8-3e7a-d9e0-708d-74419d1b50ff9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81481-803-01814810803011 VIAL, GLASS in 1 BOX (81481-803-01) / .4 mL in 1 VIAL, GLASS2024-05-06NoNoHistorical