Nilotinib

Orange BookUNIISPLATC L01EA03

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

Identification

ManufacturerEXELAN PHARMACEUTICALS INC.

CountryUS (United States)

ATC codeL01EA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7628279058
4 CARTON in 1 CARTON (76282-790-58) / 4 BLISTER PACK in 1 CARTON (76282-790-46) / 7 CAPSULE in 1 BLISTER PACK (76282-790-45)

Annotations

UNII (FDA Substance ID)

F41401512X

NILOTINIB

RxCUI 662281

Orange Book

N218922

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "F41401512X",
    "rxcui": "662281",
    "inchikey": "HHZIURLSWUIHRB-UHFFFAOYSA-N",
    "display_name": "NILOTINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4c0bc799-ce6a-822a-e063-6394a90ab748": {
      "match": "brand_token",
      "title": "NILOTINIB CAPSULE [AVKARE]",
      "spl_version": "1",
      "published_date": "2026-03-03"
    }
  },
  "productid": "76282-790_dbdd9603-ecc5-472c-8ce9-7cec9aae11f9",
  "productndc": "76282-790",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "218922",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Feb 19, 2025"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "Feb 19, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MG BASE",
        "product_no": "003",
        "approval_date": "Feb 19, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NILOTINIB",
  "proprietary_name": "Nilotinib",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218922",
  "marketing_category": "NDA",
  "nonproprietary_name": "Nilotinib",
  "start_marketing_date": "20251114",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code L01EA03.

Access this data programmatically

Query Nilotinib and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs