Home NDC 55513-123 TEZSPIRE
Product NDC 55513-123
11-digit product format 555130123
Labeler code 55513
Product ID 55513-123_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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEZEPELUMAB 210 mg/1.9mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RJ1IW3B4QX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2587794 Internal RxNorm lookup 2587800 Internal RxNorm lookup 2587803 Internal RxNorm lookup 2587806 Internal RxNorm lookup 2628920 Internal RxNorm lookup 2628923 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55513-123-01 TEZSPIRE 1.91 mL in 1 CARTRIDGE INJECTION, SOLUTION 1.91 15 55513-123-01 TEZSPIRE 1 in 1 CARTON INJECTION, SOLUTION 1 15 55513-123-96 TEZSPIRE 1 in 1 CARTON INJECTION, SOLUTION 1 15 55513-123-96 TEZSPIRE 1.91 mL in 1 CARTRIDGE INJECTION, SOLUTION 1.91 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55513-123 TEZSPIRE (TEZEPELUMAB-EKKO) INJECTION, SOLUTION [AMGEN, INC] 10 Current NDC, 4 package rows 20240130_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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761224 Tezspire tezepelumab-ekko 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55513-123-01 55513012301 1 CARTRIDGE in 1 CARTON (55513-123-01) / 1.91 mL in 1 CARTRIDGE 1 cartridge 2023-02-14 No No Current 55513-123-96 55513012396 1 CARTRIDGE in 1 CARTON (55513-123-96) / 1.91 mL in 1 CARTRIDGE 1 cartridge 2024-02-20 Yes No Current