KESIMPTA

UNIISPLATC L04AG12

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC codeL04AG12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0078100768
1 SYRINGE, GLASS in 1 CARTON (0078-1007-68) / .4 mL in 1 SYRINGE, GLASS
ndc11
0078100798
1 SYRINGE, GLASS in 1 CARTON (0078-1007-98) / .4 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

M95KG522R0

OFATUMUMAB

RxCUI 712566

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "M95KG522R0",
    "rxcui": "712566",
    "inchikey": null,
    "display_name": "OFATUMUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "6a8a3f53-2062-48ff-9dbe-b939df133ca3": {
      "match": "brand_token",
      "title": "KESIMPTA (OFATUMUMAB) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "11",
      "published_date": "2026-04-10"
    }
  },
  "productid": "0078-1007_ab75831e-d802-456a-bae6-7c85ef8dc3ed",
  "productndc": "0078-1007",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OFATUMUMAB",
  "proprietary_name": "KESIMPTA",
  "active_ingred_unit": "mg/.4mL",
  "application_number": "BLA125326",
  "marketing_category": "BLA",
  "nonproprietary_name": "ofatumumab",
  "start_marketing_date": "20091026",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code L04AG12.

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