PEMAZYRE

Orange BookUNIISPLATC L01EN02

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

Identification

ManufacturerIncyte Corporation

CountryUS (United States)

ATC codeL01EN02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5088102801
14 TABLET in 1 BOTTLE, PLASTIC (50881-028-01)

Annotations

UNII (FDA Substance ID)

Y6BX7BL23K

PEMIGATINIB

RxCUI 2359268

Orange Book

N213736

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "Y6BX7BL23K",
    "rxcui": "2359268",
    "inchikey": "HCDMJFOHIXMBOV-UHFFFAOYSA-N",
    "display_name": "PEMIGATINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9e1f2222-1d89-4e63-989c-ccebe2ab1eb4": {
      "match": "brand_token",
      "title": "PEMAZYRE (PEMIGATINIB) TABLET [INCYTE CORPORATION]",
      "spl_version": "15",
      "published_date": "2026-05-20"
    }
  },
  "productid": "50881-028_741de3ad-f255-4da5-b43a-60a99caf4137",
  "productndc": "50881-028",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213736",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "4.5MG",
        "product_no": "001",
        "approval_date": "Apr 17, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "9MG",
        "product_no": "002",
        "approval_date": "Apr 17, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "13.5MG",
        "product_no": "003",
        "approval_date": "Apr 17, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEMIGATINIB",
  "proprietary_name": "PEMAZYRE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA213736",
  "marketing_category": "NDA",
  "nonproprietary_name": "pemigatinib",
  "start_marketing_date": "20200417",
  "active_numerator_strength": "13.5"
}

Related drugs

Other records sharing ATC code L01EN02.

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