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United States · US · US:0069-0435_d85989f4-41dc-4e3a-a0fa-759b68e1130c

Cibinqo

Orange BookUNIISPLATC D11AH08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeD11AH08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0069043530
    30 TABLET, FILM COATED in 1 BOTTLE (0069-0435-30)

Annotations

UNII (FDA Substance ID)
73SM5SF3OR
ABROCITINIB
RxCUI 2591476
Orange Book
N213871
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "73SM5SF3OR",
    "rxcui": "2591476",
    "inchikey": "IUEWXNHSKRWHDY-PHIMTYICSA-N",
    "display_name": "ABROCITINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "16c12a56-4550-414b-ac9d-b785b41fea6b": {
      "match": "brand_token",
      "title": "CIBINQO (ABROCITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS]",
      "spl_version": "4",
      "published_date": "2025-03-24"
    }
  },
  "productid": "0069-0435_d85989f4-41dc-4e3a-a0fa-759b68e1130c",
  "productndc": "0069-0435",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213871",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jan 14, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jan 14, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Jan 14, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ABROCITINIB",
  "proprietary_name": "Cibinqo",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA213871",
  "marketing_category": "NDA",
  "nonproprietary_name": "abrocitinib",
  "start_marketing_date": "20220224",
  "active_numerator_strength": "200"
}

Related drugs

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