FDA.reportPublic FDA data

ZYNLONTA

Product NDC
79952-110
11-digit product format
799520110
Labeler code
79952
Product ID
79952-110_42deedca-b1fa-45ec-aea7-69ce6ecb8c96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loncastuximab tesirine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
ADC Therapeutics America, Inc.
Application
BLA761196
Marketing category
BLA
Marketing start
2021-04-30
Substance
LONCASTUXIMAB TESIRINE
Active strength
10 mg/2mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZYNLONTA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LONCASTUXIMAB TESIRINE10 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7K5O7P6QIUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2540969Internal RxNorm lookup
2540974Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
af54af12-3edf-4301-8bc5-0446bc813c1dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c26aeabf-7346-4aa4-a665-0c36575df6adProduct name120211019
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

Related label table
Related label
These highlights do not include all the information needed to use ZYNLONTA safely and effectively. See full prescribing information for ZYNLONTA. ZYNLONTA ® (loncastuximab tesirine-lpyl) for injection, for intravenous use Initial U.S. Approval: 2021
These highlights do not include all the information needed to use ZYNLONTA safely and effectively. See full prescribing information for ZYNLONTA. ZYNLONTA ® (loncastuximab tesirine-lpyl) for injection, for intravenous use Initial U.S. Approval: 2021
These highlights do not include all the information needed to use ZYNLONTA safely and effectively. See full prescribing information for ZYNLONTA. ZYNLONTA ® (loncastuximab tesirine-lpyl) for injection, for intravenous use Initial U.S. Approval: 2021
These highlights do not include all the information needed to use ZYNLONTA safely and effectively. See full prescribing information for ZYNLONTA. ZYNLONTA ® (loncastuximab tesirine-lpyl) for injection, for intravenous use Initial U.S. Approval: 2021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79952-110-01ZYNLONTA2 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,214
79952-110-01ZYNLONTA1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79952-110-01EA - Each79952-110e1fc3c41-d656-40b1-8a95-ace2be1942ca12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79952-110ZYNLONTA (LONCASTUXIMAB TESIRINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ADC THERAPEUTICS AMERICA, INC.]11Current NDC, Legacy NDC, 2 package rows20240716_af54af12-3edf-4301-8bc5-0446bc813c1d.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
ZYNLONTALONCASTUXIMAB TESIRINEADC Therapeutics America, Inc.af54af12-3edf-4301-8bc5-0446bc813c1d2026-06-12Warnings, Adverse reactionsExact identifier
application number: BLA761196
ndc (product): 79952-110

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761196Zynlontaloncastuximab tesirine-lpyl351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2540969loncastuximab tesirine-lpyl 10 MG InjectionPSNaf54af12-3edf-4301-8bc5-0446bc813c1d14
2540974Zynlonta 10 MG InjectionPSNaf54af12-3edf-4301-8bc5-0446bc813c1d14
2540974loncastuximab tesirine-lpyl 10 MG Injection [Zynlonta]SBDaf54af12-3edf-4301-8bc5-0446bc813c1d14
2540969loncastuximab tesirine-lpyl 10 MG InjectionSCDaf54af12-3edf-4301-8bc5-0446bc813c1d14
2540974Zynlonta 10 MG InjectionSYaf54af12-3edf-4301-8bc5-0446bc813c1d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
79952-110-01799520110011 VIAL, SINGLE-DOSE in 1 CARTON (79952-110-01) / 2 mL in 1 VIAL, SINGLE-DOSE2021-04-300000-00-00NoNoCurrent