NDC 0078-0669

ARZERRA

Ofatumumab

ARZERRA is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Ofatumumab.

• Product ID: 0078-0669_56665f95-5c96-4177-b65b-17928bb90b80
• NDC: 0078-0669
• Product Type: Human Prescription Drug
• Proprietary Name: ARZERRA
• Generic Name: Ofatumumab
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-02-01
• Marketing Category: BLA / BLA
• Application Number: BLA125326
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: OFATUMUMAB
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0078-0669-13

3 VIAL, SINGLE-USE in 1 CARTON (0078-0669-13) > 5 mL in 1 VIAL, SINGLE-USE (0078-0669-61)

• Marketing Start Date: 2016-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0669-84 [00078066984]

ARZERRA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125326
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-02-01
• Marketing End Date: 2016-02-01

NDC 0078-0669-13 [00078066913]

ARZERRA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125326
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-02-01

NDC 0078-0669-61 [00078066961]

ARZERRA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125326
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-02-01

Drug Details

Active Ingredients

Ingredient	Strength
OFATUMUMAB	20 mg/mL

OpenFDA Data

• SPL SET ID: 77785ce3-e8df-4ca1-8f8e-6c418c6a17de
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • M95KG522R0
• RxNorm Concept Unique ID - RxCUI:
  • 1658048
  • 1658042
  • 1658044
  • 1658047

Pharmacological Class

• CD20-directed Cytolytic Antibody [EPC]
• CD20-directed Antibody Interactions [MoA]

NDC Crossover Matching brand name "ARZERRA" or generic name "Ofatumumab"

NDC	Brand Name	Generic Name
0078-0669	ARZERRA	ofatumumab
0078-0690	ARZERRA	ofatumumab
0078-1007	KESIMPTA	ofatumumab