arzerra

Generic: ofatumumab

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name arzerra
Generic Name ofatumumab
Labeler novartis pharmaceuticals corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ofatumumab 20 mg/mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0690
Product ID 0078-0690_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)
cd20-directed cytolytic antibody [epc]
Mechanism of Action
cd20-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780690
Hyphenated Format 0078-0690

Supplemental Identifiers

RxCUI
1658042 1658044 1658047 1658048
UNII
M95KG522R0
NUI
N0000175657 N0000175078

Packaging Origin

Original Packager
true

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
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 50 mL in 1 VIAL, SINGLE-USE (0078-0690-61)
source: ndc

Packages (1)

0078-0690-61 50 mL in 1 VIAL, SINGLE-USE (0078-0690-61)

Ingredients (1)

ofatumumab (20 mg/mL)

Linked Drug Pages (1)

ARZERRA ndc-match (0.9)

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": [{"sample": false, "description": "50 mL in 1 VIAL, SINGLE-USE (0078-0690-61)", "package_ndc": "0078-0690-61", "marketing_end_date": "20260331", "marketing_start_date": "20160201"}], "brand_name": "ARZERRA", "product_id": "0078-0690_08c0da18-b3bb-4d78-9d74-00e947f39135", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]"], "product_ndc": "0078-0690", "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"}