NDC 49401-101

BENLYSTA

Belimumab

BENLYSTA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Human Genome Sciences, Inc.. The primary component is Belimumab.

• Product ID: 49401-101_0255ca36-fea3-46a1-b33a-88607d7d7064
• NDC: 49401-101
• Product Type: Human Prescription Drug
• Proprietary Name: BENLYSTA
• Generic Name: Belimumab
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-03-10
• Marketing Category: BLA / BLA
• Application Number: BLA125370
• Labeler Name: Human Genome Sciences, Inc.
• Substance Name: BELIMUMAB
• Active Ingredient Strength: 120 mg/1.5mL
• Pharm Classes: Decreased B Lymphocyte Activation [PE],B Lymphocyte Stimulator-specific Inhibitor [EPC],B Lymphocyte Stimulator-directed Antibody Interactions [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 49401-101-01

1 VIAL in 1 CARTON (49401-101-01) > 1.5 mL in 1 VIAL

• Marketing Start Date: 2011-03-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49401-101-01 [49401010101]

BENLYSTA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125370
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-03-10

Drug Details

Active Ingredients

Ingredient	Strength
BELIMUMAB	120 mg/1.5mL

OpenFDA Data

• SPL SET ID: 2fa3c528-1777-4628-8a55-a69dae2381a3
• Manufacturer:
  • Human Genome Sciences, Inc.
• UNII:
  • 73B0K5S26A
• RxNorm Concept Unique ID - RxCUI:
  • 1656398
  • 1656395
  • 1939348
  • 1939296
  • 1656402
  • 1656400
  • 1939346
  • 1939299

Pharmacological Class

• Decreased B Lymphocyte Activation [PE]
• B Lymphocyte Stimulator-specific Inhibitor [EPC]
• B Lymphocyte Stimulator-directed Antibody Interactions [MoA]

NDC Crossover Matching brand name "BENLYSTA" or generic name "Belimumab"

NDC	Brand Name	Generic Name
49401-088	BENLYSTA	belimumab
49401-101	BENLYSTA	belimumab
49401-102	BENLYSTA	belimumab