FDA.reportPublic FDA data

TEPEZZA

Product NDC
75987-130
Requested package NDC
75987-130-15
11-digit product format
759870130
Labeler code
75987
Product ID
75987-130_e8c3d1df-39fb-4af5-b4e8-3873df84afed
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
TEPEZZA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEPROTUMUMAB500 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2384f10a-36cc-4eb2-b3d9-aab3bb6f3d4dProduct name120200611
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75987-130-15TEPEZZA1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,117
75987-130-15TEPEZZA1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75987-130-15EA - Each75987-1302665a7a7-9989-43d1-91df-2c5f3806ed9b12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75987-130TEPEZZA (TEPROTUMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HORIZON THERAPEUTICS USA, INC.]11Current NDC, Legacy NDC, 2 package rows20250223_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TEPEZZATEPROTUMUMABHorizon Therapeutics USA, Inc.3e6c54a1-cefd-4a5b-a855-ab9f268b6cce2026-06-24Warnings, Adverse reactionsExact identifier
application number: BLA761143
ndc (package): 75987-130-15
ndc (product): 75987-130
ndc11 (package): 75987013015

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761143Tepezzateprotumumab-trbw351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2274812TEPEZZA 500 MG InjectionPSN3e6c54a1-cefd-4a5b-a855-ab9f268b6cce17
2274807teprotumumab-trbw 500 MG InjectionPSN3e6c54a1-cefd-4a5b-a855-ab9f268b6cce17
2274812teprotumumab-trbw 500 MG Injection [Tepezza]SBD3e6c54a1-cefd-4a5b-a855-ab9f268b6cce17
2274807teprotumumab-trbw 500 MG InjectionSCD3e6c54a1-cefd-4a5b-a855-ab9f268b6cce17
2274812Tepezza 500 MG InjectionSY3e6c54a1-cefd-4a5b-a855-ab9f268b6cce17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75987-130-15759870130151 VIAL, SINGLE-DOSE in 1 CARTON (75987-130-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2020-01-210000-00-00NoNoCurrent