NDC 0002-7716

Portrazza

Necitumumab

Portrazza is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Necitumumab.

• Product ID: 0002-7716_62de9272-71de-4b81-8ccf-ad7806f02081
• NDC: 0002-7716
• Product Type: Human Prescription Drug
• Proprietary Name: Portrazza
• Generic Name: Necitumumab
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-11-24
• Marketing Category: BLA / BLA
• Application Number: BLA125547
• Labeler Name: Eli Lilly and Company
• Substance Name: NECITUMUMAB
• Active Ingredient Strength: 16 mg/mL
• Pharm Classes: Epidermal Growth Factor Receptor Antagonist [EPC],HER1 Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0002-7716-01

1 VIAL, SINGLE-USE in 1 CARTON (0002-7716-01) > 50 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2015-11-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0002-7716-01 [00002771601]

Portrazza SOLUTION

• Marketing Category: BLA
• Application Number: BLA125547
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-11-24

Drug Details

Active Ingredients

Ingredient	Strength
NECITUMUMAB	16 mg/mL

OpenFDA Data

• SPL SET ID: 89bcf553-669a-40b0-a9d7-67a5c1d2f591
• Manufacturer:
  • Eli Lilly and Company
• UNII:
  • 2BT4C47RUI
• RxNorm Concept Unique ID - RxCUI:
  • 1723745
  • 1723750

Pharmacological Class

• Epidermal Growth Factor Receptor Antagonist [EPC]
• HER1 Antagonists [MoA]
• Epidermal Growth Factor Receptor Antagonist [EPC]
• HER1 Antagonists [MoA]