Home NDC 75987-130 TEPEZZA
Product NDC 75987-130
11-digit product format 759870130
Labeler code 75987
Product ID 75987-130_ade7436a-343e-43c8-964d-5aca91c4feaa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name teprotumumab
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Horizon Therapeutics USA, Inc.
Application BLA761143
Marketing category BLA
Marketing start 2020-01-21
Substance TEPROTUMUMAB
Active strength 500 mg/1
Pharmacologic classes Insulin-like Growth Factor-1 Receptor Inhibitor [EPC], Insulin-like Growth Factor-1 Receptor Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base TEPEZZA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEPROTUMUMAB 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y64GQ0KC0A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2274807 Internal RxNorm lookup 2274812 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 75987-130-15 TEPEZZA 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 17 75987-130-15 TEPEZZA 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75987-130 TEPEZZA (TEPROTUMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HORIZON THERAPEUTICS USA, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20250223_3e6c54a1-cefd-4a5b-a855-ab9f268b6cce.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 761143 Tepezza teprotumumab-trbw 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 75987-130-15 75987013015 1 VIAL, SINGLE-DOSE in 1 CARTON (75987-130-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2020-01-21 0000-00-00 No No Current