TEZSPIRE

Product NDC: 55513-100
Requested package NDC: 55513-100-01
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55513-100	55513-100-01	D	Discontinued by firm		2026-08-07

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 date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55513-100	55513-100-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55513-100	55513-100-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dcda8adb-29c0-4f01-aff6-2e9233ef700d	Product name	1	20220720
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55513-100-01	TEZSPIRE	1.91 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	1.91	15
55513-100-01	TEZSPIRE	1 in 1 CARTON	INJECTION, SOLUTION	1	15
55513-100-96	TEZSPIRE	1.91 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	1.91	15
55513-100-96	TEZSPIRE	1 in 1 CARTON	INJECTION, SOLUTION	1	15
55513-100-99	TEZSPIRE	1.91 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	1.91	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55513-100	TEZSPIRE (TEZEPELUMAB-EKKO) INJECTION, SOLUTION [AMGEN, INC]	10	Legacy NDC, 5 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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TEZSPIRE	TEZEPELUMAB-EKKO	Amgen Inc	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	2025-10-17	Warnings, Adverse reactions	Exact identifier application number: BLA761224 ndc (package): 55513-100-01 ndc (product): 55513-100 ndc11 (package): 55513010001

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RJ1IW3B4QX	TEZEPELUMAB	1572943-04-4	TEZEPELUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2628920	tezepelumab-ekko 210 MG in 1.91 ML Auto-Injector	PSN	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587794	tezepelumab-ekko 210 MG in 1.91 ML Injection	PSN	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587803	tezepelumab-ekko 210 MG in 1.91 ML Prefilled Syringe	PSN	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2628923	Tezspire 210 MG in 1.91 ML Auto-Injector	PSN	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587800	Tezspire 210 MG in 1.91 ML Injection	PSN	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587806	Tezspire 210 MG in 1.91 ML Prefilled Syringe	PSN	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2628923	1.91 ML tezepelumab-ekko 110 MG/ML Auto-Injector [Tezspire]	SBD	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587800	1.91 ML tezepelumab-ekko 110 MG/ML Injection [Tezspire]	SBD	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587806	1.91 ML tezepelumab-ekko 110 MG/ML Prefilled Syringe [Tezspire]	SBD	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2628920	1.91 ML tezepelumab-ekko 110 MG/ML Auto-Injector	SCD	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587794	1.91 ML tezepelumab-ekko 110 MG/ML Injection	SCD	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587803	1.91 ML tezepelumab-ekko 110 MG/ML Prefilled Syringe	SCD	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2628923	1.91 ML Tezspire 110 MG/ML Auto-Injector	SY	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587800	1.91 ML Tezspire 110 MG/ML Injection	SY	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587806	1.91 ML Tezspire 110 MG/ML Prefilled Syringe	SY	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2628920	tezepelumab-ekko 210 MG per 1.91 ML Auto-Injector	SY	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587794	tezepelumab-ekko 210 MG per 1.91 ML Injection	SY	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587803	tezepelumab-ekko 210 MG per 1.91 ML Prefilled Syringe	SY	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2628923	Tezspire 210 MG per 1.91 ML Auto-Injector	SY	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587800	Tezspire 210 MG per 1.91 ML Injection	SY	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15
2587806	Tezspire 210 MG per 1.91 ML Prefilled Syringe	SY	60f0aa03-ad25-4d48-80ce-7fcfa76f325f	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55513-100-01	55513010001	1 VIAL, GLASS in 1 CARTON (55513-100-01) > 1.91 mL in 1 VIAL, GLASS	2021-12-17	0000-00-00	No	No	Current