INLYTA

Orange BookUNIISPLATC L01EK01

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

Identification

ManufacturerU.S. Pharmaceuticals

CountryUS (United States)

ATC codeL01EK01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6353904402
30 TABLET, FILM COATED in 1 BOTTLE (63539-044-02)

Annotations

UNII (FDA Substance ID)

C9LVQ0YUXG

AXITINIB

RxCUI 1242999

Orange Book

N202324

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "C9LVQ0YUXG",
    "rxcui": "1242999",
    "inchikey": "RITAVMQDGBJQJZ-FMIVXFBMSA-N",
    "display_name": "AXITINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8a903e31-936e-4ed7-8a59-59f32374f338": {
      "match": "brand_token",
      "title": "INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS]",
      "spl_version": "12",
      "published_date": "2026-03-16"
    }
  },
  "productid": "63539-044_0c63e82e-8c0d-4177-8748-20c2ece2b5e6",
  "productndc": "63539-044",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202324",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Jan 27, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Jan 27, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AXITINIB",
  "proprietary_name": "INLYTA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202324",
  "marketing_category": "NDA",
  "nonproprietary_name": "axitinib",
  "start_marketing_date": "20120127",
  "active_numerator_strength": "5"
}

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