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United States · US · US:50474-350_433f8057-35f8-f7e8-e063-6294a90a3ffd

KYGEVVI

Orange BookUNIISPLATC A16AX

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

Identification

ManufacturerUCB, Inc.
CountryUS (United States)
ATC codeA16AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5047435030
    30 PACKET in 1 CARTON (50474-350-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (50474-350-01)

Annotations

UNII (FDA Substance ID)
0W860991D6
DOXECITINE
Orange Book
N219792
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0W860991D6",
    "rxcui": null,
    "inchikey": "CKTSBUTUHBMZGZ-SHYZEUOFSA-N",
    "display_name": "DOXECITINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7d5ce670-9314-4fd7-8b0a-1447910dcf9e": {
      "match": "brand_token",
      "title": "KYGEVVI (DOXECITINE AND DOXRIBTIMINE) POWDER, FOR SOLUTION [UCB, INC.]",
      "spl_version": "3",
      "published_date": "2026-03-02"
    }
  },
  "productid": "50474-350_433f8057-35f8-f7e8-e063-6294a90a3ffd",
  "productndc": "50474-350",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "219792",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2GM/PACKET;2GM/PACKET",
        "product_no": "001",
        "approval_date": "Nov 3, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXECITINE; DOXRIBTIMINE",
  "proprietary_name": "KYGEVVI",
  "active_ingred_unit": "g/1; g/1",
  "application_number": "NDA219792",
  "marketing_category": "NDA",
  "nonproprietary_name": "doxecitine and doxribtimine",
  "start_marketing_date": "20260301",
  "active_numerator_strength": "2; 2"
}

Related drugs

Other records sharing ATC code A16AX.

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