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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7TK323DLA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2682684Internal RxNorm lookup
2682691Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eae31db8-3e7a-d9e0-708d-74419d1b50ffAvailable on FDA.report

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

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
ANKTIVANOGAPENDEKIN ALFA INBAKICEPT-PMLNAltor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.eae31db8-3e7a-d9e0-708d-74419d1b50ff2025-06-24Warnings, Adverse reactionsExact identifier
application number: BLA761336
ndc (product): 81481-803

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761336Anktivanogapendekin alfa inbakicept-pmln351(a)Rx2026-08-01

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, GLASS2024-05-06NoNoCurrent