tezspire

Generic: tezepelumab-ekko

Labeler: amgen inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name tezspire
Generic Name tezepelumab-ekko
Labeler amgen inc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

tezepelumab 210 mg/1.9mL

Manufacturer
Amgen Inc

Identifiers & Regulatory

Product NDC 55513-112
Product ID 55513-112_7aa761f9-01a0-48d3-a553-fa93fee5f243
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761224
Listing Expiration 2026-12-31
Marketing Start 2021-12-17

Pharmacologic Class

Established (EPC)
thymic stromal lymphopoietin blocker [epc]
Mechanism of Action
thymic stromal lymphopoietin blockers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513112
Hyphenated Format 55513-112

Supplemental Identifiers

RxCUI
2587794 2587800 2587803 2587806 2628920 2628923
UNII
RJ1IW3B4QX
NUI
N0000194010 N0000194011

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tezspire (source: ndc)
Generic Name tezepelumab-ekko (source: ndc)
Application Number BLA761224 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 210 mg/1.9mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (55513-112-01) / 1.91 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (55513-112-96) / 1.91 mL in 1 SYRINGE
  • 1.91 mL in 1 SYRINGE (55513-112-99)
source: ndc

Packages (3)

55513-112-01 1 SYRINGE in 1 CARTON (55513-112-01) / 1.91 mL in 1 SYRINGE 55513-112-96 1 SYRINGE in 1 CARTON (55513-112-96) / 1.91 mL in 1 SYRINGE 55513-112-99 1.91 mL in 1 SYRINGE (55513-112-99)

Ingredients (1)

tezepelumab (210 mg/1.9mL)

Linked Drug Pages (1)

TEZSPIRE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "7aa761f9-01a0-48d3-a553-fa93fee5f243", "openfda": {"nui": ["N0000194010", "N0000194011"], "unii": ["RJ1IW3B4QX"], "rxcui": ["2587794", "2587800", "2587803", "2587806", "2628920", "2628923"], "spl_set_id": ["60f0aa03-ad25-4d48-80ce-7fcfa76f325f"], "pharm_class_epc": ["Thymic Stromal Lymphopoietin Blocker [EPC]"], "pharm_class_moa": ["Thymic Stromal Lymphopoietin Blockers [MoA]"], "manufacturer_name": ["Amgen Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (55513-112-01)  / 1.91 mL in 1 SYRINGE", "package_ndc": "55513-112-01", "marketing_start_date": "20211217"}, {"sample": true, "description": "1 SYRINGE in 1 CARTON (55513-112-96)  / 1.91 mL in 1 SYRINGE", "package_ndc": "55513-112-96", "marketing_start_date": "20211217"}, {"sample": true, "description": "1.91 mL in 1 SYRINGE (55513-112-99)", "package_ndc": "55513-112-99", "marketing_start_date": "20211217"}], "brand_name": "TEZSPIRE", "product_id": "55513-112_7aa761f9-01a0-48d3-a553-fa93fee5f243", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Thymic Stromal Lymphopoietin Blocker [EPC]", "Thymic Stromal Lymphopoietin Blockers [MoA]"], "product_ndc": "55513-112", "generic_name": "tezepelumab-ekko", "labeler_name": "Amgen Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEZSPIRE", "active_ingredients": [{"name": "TEZEPELUMAB", "strength": "210 mg/1.9mL"}], "application_number": "BLA761224", "marketing_category": "BLA", "marketing_start_date": "20211217", "listing_expiration_date": "20261231"}