tepezza

Generic: teprotumumab

Labeler: horizon therapeutics usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name tepezza
Generic Name teprotumumab
Labeler horizon therapeutics usa, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

teprotumumab 500 mg/1

Manufacturer
Horizon Therapeutics USA, Inc.

Identifiers & Regulatory

Product NDC 75987-130
Product ID 75987-130_ade7436a-343e-43c8-964d-5aca91c4feaa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761143
Listing Expiration 2026-12-31
Marketing Start 2020-01-21

Pharmacologic Class

Established (EPC)
insulin-like growth factor-1 receptor inhibitor [epc]
Mechanism of Action
insulin-like growth factor-1 receptor inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75987130
Hyphenated Format 75987-130

Supplemental Identifiers

RxCUI
2274807 2274812
UNII
Y64GQ0KC0A
NUI
N0000193926 N0000193927

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 tepezza (source: ndc)
Generic Name teprotumumab (source: ndc)
Application Number BLA761143 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (75987-130-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

75987-130-15 1 VIAL, SINGLE-DOSE in 1 CARTON (75987-130-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

teprotumumab (500 mg/1)

Linked Drug Pages (1)

TEPEZZA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ade7436a-343e-43c8-964d-5aca91c4feaa", "openfda": {"nui": ["N0000193926", "N0000193927"], "unii": ["Y64GQ0KC0A"], "rxcui": ["2274807", "2274812"], "spl_set_id": ["3e6c54a1-cefd-4a5b-a855-ab9f268b6cce"], "pharm_class_epc": ["Insulin-like Growth Factor-1 Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Insulin-like Growth Factor-1 Receptor Inhibitors [MoA]"], "manufacturer_name": ["Horizon Therapeutics USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (75987-130-15)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "75987-130-15", "marketing_start_date": "20200121"}], "brand_name": "TEPEZZA", "product_id": "75987-130_ade7436a-343e-43c8-964d-5aca91c4feaa", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Insulin-like Growth Factor-1 Receptor Inhibitor [EPC]", "Insulin-like Growth Factor-1 Receptor Inhibitors [MoA]"], "product_ndc": "75987-130", "generic_name": "teprotumumab", "labeler_name": "Horizon Therapeutics USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEPEZZA", "active_ingredients": [{"name": "TEPROTUMUMAB", "strength": "500 mg/1"}], "application_number": "BLA761143", "marketing_category": "BLA", "marketing_start_date": "20200121", "listing_expiration_date": "20261231"}