NDC 75987-130

TEPEZZA

Teprotumumab

TEPEZZA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Horizon Therapeutics Usa, Inc.. The primary component is Teprotumumab.

• Product ID: 75987-130_22ea125f-0f2c-4413-82ca-6862225da222
• NDC: 75987-130
• Product Type: Human Prescription Drug
• Proprietary Name: TEPEZZA
• Generic Name: Teprotumumab
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-01-21
• Marketing Category: BLA / BLA
• Application Number: BLA761143
• Labeler Name: Horizon Therapeutics USA, Inc.
• Substance Name: TEPROTUMUMAB
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Insulin-like Growth Factor-1 Receptor Inhibitor [EPC], Insulin-like Growth Factor-1 Receptor Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 75987-130-15

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

• Marketing Start Date: 2020-01-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 75987-130-15 [75987013015]

TEPEZZA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA761143
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-01-21

Drug Details

Active Ingredients

Ingredient	Strength
TEPROTUMUMAB	500 mg/1