arzerra
Generic: ofatumumab
Labeler: novartis pharmaceuticals corporationDrug Facts
Product Profile
Brand Name
arzerra
Generic Name
ofatumumab
Labeler
novartis pharmaceuticals corporation
Dosage Form
INJECTION, SOLUTION
Routes
Active Ingredients
ofatumumab 20 mg/mL
Manufacturer
Identifiers & Regulatory
Product NDC
0078-0669
Product ID
0078-0669_08c0da18-b3bb-4d78-9d74-00e947f39135
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
BLA
Application Number
BLA125326
Marketing Start
2016-02-01
Marketing End
2026-03-31
Pharmacologic Class
Established (EPC)
Mechanism of Action
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
00780669
Hyphenated Format
0078-0669
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
Resolved Product View
Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.
Resolved Identity
Brand Name
arzerra (source: ndc)
Generic Name
ofatumumab (source: ndc)
Application Number
BLA125326 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 20 mg/mL
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING ARZERRA (ofatumumab) is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate (20 mg/mL) for dilution and intravenous administration provided in single-use glass vials with a rubber stopper (not made with natural rubber latex) and an aluminum overseal. Each vial contains either 100 mg ofatumumab in 5 mL of solution or 1,000 mg ofatumumab in 50 mL of solution. ARZERRA is available as follows: Carton Contents NDC 3 single-use 100 mg/5 mL vials Vial: NDC 0078-0669-61 Carton of 3 vials: NDC 0078-0669-13 1 single-use 1,000 mg/50 mL vial Vial and Carton: NDC 0078-0690-61 Store ARZERRA refrigerated between 2° to 8°C (36° to 46°F). Do not freeze. Vials should be protected from light.
- Principal Display Panel NDC 0078-0669-13 Arzerra ® (ofatumumab) Injection, for Intravenous Infusion 100 mg/5 mL(20mg/mL) Rx only For Intravenous Infusion Only. Must Be Diluted Prior To Administration. Contains 3 vials Single-Use Vials - Discard Unused Portion Novartis arzerra principal display panel
- Principal Display Panel NDC 0078-0690-61 Arzerra ® (ofatumumab) Injection, for Intravenous Infusion 1000 mg/50 mL(20mg/mL) Rx only For Intravenous Infusion Only. Must Be Diluted Prior To Administration. Contains 1 vial Single-Use Vials - Discard Unused Portion Novartis arzerra principal display panel
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "08c0da18-b3bb-4d78-9d74-00e947f39135", "openfda": {"nui": ["N0000175657", "N0000175078"], "unii": ["M95KG522R0"], "rxcui": ["1658042", "1658044", "1658047", "1658048"], "spl_set_id": ["77785ce3-e8df-4ca1-8f8e-6c418c6a17de"], "pharm_class_epc": ["CD20-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD20-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "ARZERRA", "product_id": "0078-0669_08c0da18-b3bb-4d78-9d74-00e947f39135", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]"], "product_ndc": "0078-0669", "generic_name": "ofatumumab", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ARZERRA", "active_ingredients": [{"name": "OFATUMUMAB", "strength": "20 mg/mL"}], "application_number": "BLA125326", "marketing_category": "BLA", "marketing_end_date": "20260331", "marketing_start_date": "20160201"}