NDC 25682-001

SOLIRIS

Eculizumab

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

• Product ID: 25682-001_04229ed1-8ddc-46e4-a54c-dd016bdb59ef
• NDC: 25682-001
• Product Type: Human Prescription Drug
• Proprietary Name: SOLIRIS
• Generic Name: Eculizumab
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2007-04-02
• Marketing Category: BLA / BLA
• Application Number: BLA125166
• Labeler Name: Alexion Pharmaceuticals Inc.
• Substance Name: ECULIZUMAB
• Active Ingredient Strength: 300 mg/30mL
• Pharm Classes: Complement Inhibitor [EPC],Complement Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 25682-001-01

1 VIAL in 1 CARTON (25682-001-01) > 30 mL in 1 VIAL

• Marketing Start Date: 2007-04-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 25682-001-01 [25682000101]

SOLIRIS INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA125166
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2007-04-02

Drug Details

Active Ingredients

Ingredient	Strength
ECULIZUMAB	300 mg/30mL

Pharmacological Class

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