VYKAT XR

Orange BookUNIISPLATC C02DA

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

Identification

ManufacturerSoleno Therapeutics, Inc.

CountryUS (United States)

ATC codeC02DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8386007501
30 TABLET, FILM COATED in 1 BOTTLE (83860-075-01)

Annotations

UNII (FDA Substance ID)

2U8NRZ7P8L

DIAZOXIDE CHOLINE

Orange Book

N216665

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2U8NRZ7P8L",
    "rxcui": null,
    "inchikey": "YLLWQNAEYILHLV-UHFFFAOYSA-N",
    "display_name": "DIAZOXIDE CHOLINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0e745e85-9512-e360-e063-6394a90aebf1": {
      "match": "brand_token",
      "title": "VYKAT XR (DIAZOXIDE CHOLINE) TABLET, FILM COATED [SOLENO THERAPEUTICS, INC.]",
      "spl_version": "2",
      "published_date": "2025-04-10"
    }
  },
  "productid": "83860-075_b8413ebc-f835-4c45-9524-91bda45bd35f",
  "productndc": "83860-075",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216665",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Mar 26, 2025"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "75MG",
        "product_no": "002",
        "approval_date": "Mar 26, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Mar 26, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIAZOXIDE CHOLINE",
  "proprietary_name": "VYKAT XR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216665",
  "marketing_category": "NDA",
  "nonproprietary_name": "diazoxide choline",
  "start_marketing_date": "20250326",
  "active_numerator_strength": "75"
}

Related drugs

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