JAKAFI

Orange BookUNIISPLATC D11AH09

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

Identification

ManufacturerIncyte Corporation

CountryUS (United States)

ATC codeD11AH09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5088101001
28 TABLET in 1 BOTTLE, PLASTIC (50881-010-01)
ndc11
5088101060
60 TABLET in 1 BOTTLE, PLASTIC (50881-010-60)

Annotations

UNII (FDA Substance ID)

82S8X8XX8H

RUXOLITINIB

RxCUI 1193326

Orange Book

N202192

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "82S8X8XX8H",
    "rxcui": "1193326",
    "inchikey": "HFNKQEVNSGCOJV-OAHLLOKOSA-N",
    "display_name": "RUXOLITINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f1c82580-87ae-11e0-bc84-0002a5d5c51b": {
      "match": "brand_token",
      "title": "JAKAFI (RUXOLITINIB) TABLET JAKAFI XR (RUXOLITINIB) TABLET, EXTENDED RELEASE [INCYTE CORPORATION]",
      "spl_version": "40",
      "published_date": "2026-05-11"
    }
  },
  "productid": "50881-010_baf91401-9bd0-4ce6-a5c4-7ca5c572f106",
  "productndc": "50881-010",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202192",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Nov 16, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Nov 16, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 15MG BASE",
        "product_no": "003",
        "approval_date": "Nov 16, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "Nov 16, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE",
        "product_no": "005",
        "approval_date": "Nov 16, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RUXOLITINIB",
  "proprietary_name": "JAKAFI",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202192",
  "marketing_category": "NDA",
  "nonproprietary_name": "ruxolitinib",
  "start_marketing_date": "20111116",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code D11AH09.

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