NDC 25682-022

Ultomiris

Ravulizumab

Ultomiris is a Intravenous Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Alexion Pharmaceuticals Inc.. The primary component is Ravulizumab.

• Product ID: 25682-022_0584968e-282e-4a10-aa66-f0329d41f571
• NDC: 25682-022
• Product Type: Human Prescription Drug
• Proprietary Name: Ultomiris
• Generic Name: Ravulizumab
• Dosage Form: Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-12-21
• Marketing Category: BLA / BLA
• Application Number: BLA761108
• Labeler Name: Alexion Pharmaceuticals Inc.
• Substance Name: RAVULIZUMAB
• Active Ingredient Strength: 300 mg/30mL
• Pharm Classes: Complement Inhibitor [EPC],Complement Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 25682-022-01

1 VIAL, GLASS in 1 CARTON (25682-022-01) > 30 mL in 1 VIAL, GLASS

• Marketing Start Date: 2018-12-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 25682-022-01 [25682002201]

Ultomiris SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA761108
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-12-21

Drug Details

Active Ingredients

Ingredient	Strength
RAVULIZUMAB	300 mg/30mL

OpenFDA Data

• SPL SET ID: a9a590d9-0217-43c7-908d-e62a71279791
• Manufacturer:
  • Alexion Pharmaceuticals Inc.
• UNII:
  • C3VX249T6L
• RxNorm Concept Unique ID - RxCUI:
  • 2107325
  • 2107320

Pharmacological Class

• Complement Inhibitor [EPC]
• Complement Inhibitors [MoA]

NDC Crossover Matching brand name "Ultomiris" or generic name "Ravulizumab"

NDC	Brand Name	Generic Name
25682-022	Ultomiris	ravulizumab
25682-025	Ultomiris	ravulizumab
25682-028	Ultomiris	ravulizumab