FDA.reportPublic FDA data

TEPEZZA

Product NDC
75987-130
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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Y64GQ0KC0AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2274807Internal RxNorm lookup
2274812Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e6c54a1-cefd-4a5b-a855-ab9f268b6cceAvailable on FDA.report

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761143Tepezzateprotumumab-trbw351(a)Rx2026-10-01

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