FDA.reportPublic FDA data

TEZSPIRE

Product NDC
55513-112
11-digit product format
555130112
Labeler code
55513
Product ID
55513-112_7aa761f9-01a0-48d3-a553-fa93fee5f243
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
Substance
TEZEPELUMAB
Active strength
210 mg/1.9mL
Pharmacologic classes
Thymic Stromal Lymphopoietin Blocker [EPC], Thymic Stromal Lymphopoietin Blockers [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEZEPELUMAB210 mg/1.9mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRJ1IW3B4QX
Rxcui2587794, 2587800, 2587803, 2587806, 2628920, 2628923

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
55513-112-01TEZSPIRE1 in 1 CARTONINJECTION, SOLUTION115
55513-112-01TEZSPIRE1.91 mL in 1 SYRINGEINJECTION, SOLUTION1.9115
55513-112-96TEZSPIRE1 in 1 CARTONINJECTION, SOLUTION115
55513-112-96TEZSPIRE1.91 mL in 1 SYRINGEINJECTION, SOLUTION1.9115
55513-112-99TEZSPIRE1.91 mL in 1 SYRINGEINJECTION, SOLUTION1.9115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-112-01ML - Milliliter55513-11202bb97c2-c6e2-4a9e-8b8f-30c499279cc212022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-112TEZSPIRE (TEZEPELUMAB-EKKO) INJECTION, SOLUTION [AMGEN, INC]10Current NDC, Legacy NDC, 5 package rows20240130_60f0aa03-ad25-4d48-80ce-7fcfa76f325f.zip

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-112-01555130112011 SYRINGE in 1 CARTON (55513-112-01) / 1.91 mL in 1 SYRINGE1 syringe2021-12-170000-00-00NoNoCurrent
55513-112-96555130112961 SYRINGE in 1 CARTON (55513-112-96) / 1.91 mL in 1 SYRINGE1 syringe2021-12-170000-00-00YesNoCurrent
55513-112-99555130112991.91 mL in 1 SYRINGE (55513-112-99) 1.91 ml2021-12-170000-00-00YesNoCurrent