FDA.reportPublic FDA data

TEZSPIRE

Product NDC
55513-100
Requested package NDC
55513-100-96
11-digit product format
555130100
Labeler code
55513
Product ID
55513-100_25a4a901-927c-4f3a-a1c4-72826d46e946
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tezepelumab-ekko
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Amgen, Inc
Application
BLA761224
Marketing category
BLA
Marketing start
2021-12-17
Marketing end
0000-00-00
Substance
TEZEPELUMAB
Active strength
210 mg/1.9mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55513-10055513-100-96DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55513-10055513-100-96DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55513-10055513-100-96DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dcda8adb-29c0-4f01-aff6-2e9233ef700dProduct name120220720
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-100-01TEZSPIRE1.91 mL in 1 VIAL, GLASSINJECTION, SOLUTION1.9115
55513-100-01TEZSPIRE1 in 1 CARTONINJECTION, SOLUTION115
55513-100-96TEZSPIRE1.91 mL in 1 VIAL, GLASSINJECTION, SOLUTION1.9115
55513-100-96TEZSPIRE1 in 1 CARTONINJECTION, SOLUTION115
55513-100-99TEZSPIRE1.91 mL in 1 VIAL, GLASSINJECTION, SOLUTION1.9115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-100TEZSPIRE (TEZEPELUMAB-EKKO) INJECTION, SOLUTION [AMGEN, INC]10Legacy NDC, 5 package rows20240130_60f0aa03-ad25-4d48-80ce-7fcfa76f325f.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
TEZSPIRETEZEPELUMAB-EKKOAmgen Inc60f0aa03-ad25-4d48-80ce-7fcfa76f325f2025-10-17Warnings, Adverse reactionsExact identifier
application number: BLA761224
ndc (package): 55513-100-96
ndc (product): 55513-100
ndc11 (package): 55513010096

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761224Tezspiretezepelumab-ekko351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2628920tezepelumab-ekko 210 MG in 1.91 ML Auto-InjectorPSN60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
2587794tezepelumab-ekko 210 MG in 1.91 ML InjectionPSN60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
2587803tezepelumab-ekko 210 MG in 1.91 ML Prefilled SyringePSN60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
2628923Tezspire 210 MG in 1.91 ML Auto-InjectorPSN60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
2587800Tezspire 210 MG in 1.91 ML InjectionPSN60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
2587806Tezspire 210 MG in 1.91 ML Prefilled SyringePSN60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
26289231.91 ML tezepelumab-ekko 110 MG/ML Auto-Injector [Tezspire]SBD60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
25878001.91 ML tezepelumab-ekko 110 MG/ML Injection [Tezspire]SBD60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
25878061.91 ML tezepelumab-ekko 110 MG/ML Prefilled Syringe [Tezspire]SBD60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
26289201.91 ML tezepelumab-ekko 110 MG/ML Auto-InjectorSCD60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
25877941.91 ML tezepelumab-ekko 110 MG/ML InjectionSCD60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
25878031.91 ML tezepelumab-ekko 110 MG/ML Prefilled SyringeSCD60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
26289231.91 ML Tezspire 110 MG/ML Auto-InjectorSY60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
25878001.91 ML Tezspire 110 MG/ML InjectionSY60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
25878061.91 ML Tezspire 110 MG/ML Prefilled SyringeSY60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
2628920tezepelumab-ekko 210 MG per 1.91 ML Auto-InjectorSY60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
2587794tezepelumab-ekko 210 MG per 1.91 ML InjectionSY60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
2587803tezepelumab-ekko 210 MG per 1.91 ML Prefilled SyringeSY60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
2628923Tezspire 210 MG per 1.91 ML Auto-InjectorSY60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
2587800Tezspire 210 MG per 1.91 ML InjectionSY60f0aa03-ad25-4d48-80ce-7fcfa76f325f15
2587806Tezspire 210 MG per 1.91 ML Prefilled SyringeSY60f0aa03-ad25-4d48-80ce-7fcfa76f325f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55513-100-96555130100961 VIAL, GLASS in 1 CARTON (55513-100-96) > 1.91 mL in 1 VIAL, GLASS2021-12-170000-00-00YesNoCurrent