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United States · US · US:0003-0895_9d2e509f-3c81-45c7-984b-4e3c8b56dbef

SOTYKTU

Orange BookUNIISPLATC L04AF07

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

Identification

ManufacturerE.R. Squibb & Sons, L.L.C.
CountryUS (United States)
ATC codeL04AF07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0003089511
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11)
  • ndc11
    0003089591
    30 TABLET, FILM COATED in 1 BLISTER PACK (0003-0895-91)

Annotations

UNII (FDA Substance ID)
N0A21N6RAU
DEUCRAVACITINIB
RxCUI 2612087
Orange Book
N214958
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "N0A21N6RAU",
    "rxcui": "2612087",
    "inchikey": "BZZKEPGENYLQSC-FIBGUPNXSA-N",
    "display_name": "DEUCRAVACITINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ff4d7258-5068-4cdf-9692-8cae04c3198e": {
      "match": "brand_token",
      "title": "SOTYKTU (DEUCRAVACITINIB) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]",
      "spl_version": "2",
      "published_date": "2026-03-18"
    }
  },
  "productid": "0003-0895_9d2e509f-3c81-45c7-984b-4e3c8b56dbef",
  "productndc": "0003-0895",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214958",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "6MG",
        "product_no": "001",
        "approval_date": "Sep 9, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEUCRAVACITINIB",
  "proprietary_name": "SOTYKTU",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214958",
  "marketing_category": "NDA",
  "nonproprietary_name": "deucravacitinib",
  "start_marketing_date": "20220909",
  "active_numerator_strength": "6"
}

Related drugs

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