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United States · US · US:72893-017_2437f76e-6dda-487c-8c3d-aa1a9059af2d

ADQUEY

Orange BookUNIISPL

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

Identification

ManufacturerAcrotech Biopharma Inc
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7289301707
    3 g in 1 TUBE (72893-017-07)
  • ndc11
    7289301708
    27 g in 1 TUBE (72893-017-08)
  • ndc11
    7289301709
    85 g in 1 TUBE (72893-017-09)

Annotations

UNII (FDA Substance ID)
T3U32GLJ0F
DIFAMILAST
Orange Book
N219474
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "T3U32GLJ0F",
    "rxcui": null,
    "inchikey": "VFBILHPIHUPBPZ-UHFFFAOYSA-N",
    "display_name": "DIFAMILAST",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "46c95e41-fa29-4e11-9d94-0fd4f0291c34": {
      "match": "brand_token",
      "title": "ADQUEY (DIFAMILAST) OINTMENT [ACROTECH BIOPHARMA INC]",
      "spl_version": "4",
      "published_date": "2026-05-14"
    }
  },
  "productid": "72893-017_2437f76e-6dda-487c-8c3d-aa1a9059af2d",
  "productndc": "72893-017",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "219474",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Feb 12, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIFAMILAST",
  "proprietary_name": "ADQUEY",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA219474",
  "marketing_category": "NDA",
  "nonproprietary_name": "Difamilast",
  "start_marketing_date": "20260225",
  "active_numerator_strength": "10"
}

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