NDC 66733-958

ERBITUX

Cetuximab

ERBITUX is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Imclone Llc. The primary component is Cetuximab.

• Product ID: 66733-958_0eb3bea0-63e0-4a5d-8e49-e83b095f641a
• NDC: 66733-958
• Product Type: Human Prescription Drug
• Proprietary Name: ERBITUX
• Generic Name: Cetuximab
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2007-10-02
• Marketing Category: BLA / BLA
• Application Number: BLA125084
• Labeler Name: ImClone LLC
• Substance Name: CETUXIMAB
• Active Ingredient Strength: 2 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 66733-958-23

1 VIAL, SINGLE-DOSE in 1 CARTON (66733-958-23) > 100 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2007-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66733-958-23 [66733095823]

ERBITUX SOLUTION

• Marketing Category: BLA
• Application Number: BLA125084
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2007-10-02

Drug Details

Active Ingredients

Ingredient	Strength
CETUXIMAB	2 mg/mL

OpenFDA Data

• SPL SET ID: 8bc6397e-4bd8-4d37-a007-a327e4da34d9
• Manufacturer:
  • ImClone LLC
• UNII:
  • PQX0D8J21J
• RxNorm Concept Unique ID - RxCUI:
  • 1657664
  • 1657658
  • 1657660
  • 1657663

Pharmacological Class

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

NDC Crossover Matching brand name "ERBITUX" or generic name "Cetuximab"

NDC	Brand Name	Generic Name
66733-948	ERBITUX	cetuximab
66733-958	ERBITUX	cetuximab