ARZERRA

Generic: ofatumumab

Labeler: Novartis Pharmaceuticals Corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Active

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

Identifiers & Regulatory

Product NDC 0078-0669
Product ID 0078-0669_eaccfff4-b2fd-49e0-88f8-ca3ce2738be7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125326
Listing Expiration 2026-12-31
Marketing Start 2016-02-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780669
Hyphenated Format 0078-0669

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
  • 3 VIAL, SINGLE-USE in 1 CARTON (0078-0669-13) / 5 mL in 1 VIAL, SINGLE-USE (0078-0669-61)
source: ndc

Packages (1)

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

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": "eaccfff4-b2fd-49e0-88f8-ca3ce2738be7", "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": "3 VIAL, SINGLE-USE in 1 CARTON (0078-0669-13)  / 5 mL in 1 VIAL, SINGLE-USE (0078-0669-61)", "package_ndc": "0078-0669-13", "marketing_start_date": "20160201"}], "brand_name": "ARZERRA", "product_id": "0078-0669_eaccfff4-b2fd-49e0-88f8-ca3ce2738be7", "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_start_date": "20160201", "listing_expiration_date": "20261231"}