kesimpta

Generic: ofatumumab

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

Drug Facts

Product Profile

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

ofatumumab 20 mg/.4mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-1007
Product ID 0078-1007_2a949531-807f-4e6e-9ac0-68943e6c6685
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125326
Listing Expiration 2026-12-31
Marketing Start 2009-10-26

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 00781007
Hyphenated Format 0078-1007

Supplemental Identifiers

RxCUI
2390949 2390954
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 kesimpta (source: ndc)
Generic Name ofatumumab (source: ndc)
Application Number BLA125326 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/.4mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (0078-1007-68) / .4 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 CARTON (0078-1007-98) / .4 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

0078-1007-68 1 SYRINGE, GLASS in 1 CARTON (0078-1007-68) / .4 mL in 1 SYRINGE, GLASS 0078-1007-98 1 SYRINGE, GLASS in 1 CARTON (0078-1007-98) / .4 mL in 1 SYRINGE, GLASS

Ingredients (1)

ofatumumab (20 mg/.4mL)

Linked Drug Pages (1)

KESIMPTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "2a949531-807f-4e6e-9ac0-68943e6c6685", "openfda": {"nui": ["N0000175657", "N0000175078"], "unii": ["M95KG522R0"], "rxcui": ["2390949", "2390954"], "spl_set_id": ["6a8a3f53-2062-48ff-9dbe-b939df133ca3"], "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": "1 SYRINGE, GLASS in 1 CARTON (0078-1007-68)  / .4 mL in 1 SYRINGE, GLASS", "package_ndc": "0078-1007-68", "marketing_start_date": "20200820"}, {"sample": true, "description": "1 SYRINGE, GLASS in 1 CARTON (0078-1007-98)  / .4 mL in 1 SYRINGE, GLASS", "package_ndc": "0078-1007-98", "marketing_start_date": "20200820"}], "brand_name": "KESIMPTA", "product_id": "0078-1007_2a949531-807f-4e6e-9ac0-68943e6c6685", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]"], "product_ndc": "0078-1007", "generic_name": "ofatumumab", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KESIMPTA", "active_ingredients": [{"name": "OFATUMUMAB", "strength": "20 mg/.4mL"}], "application_number": "BLA125326", "marketing_category": "BLA", "marketing_start_date": "20091026", "listing_expiration_date": "20261231"}