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United States · US · US:72065-001_1a581a6b-8813-42ed-8892-21c2341b62c0

Keveyis

Orange BookUNIISPLATC S01EC02

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

Identification

ManufacturerXeris Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeS01EC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7206500101
    100 TABLET in 1 BOTTLE (72065-001-01)

Annotations

UNII (FDA Substance ID)
VVJ6673MHY
DICHLORPHENAMIDE
RxCUI 3353
Orange Book
N011366
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "VVJ6673MHY",
    "rxcui": "3353",
    "inchikey": "GJQPMPFPNINLKP-UHFFFAOYSA-N",
    "display_name": "DICHLORPHENAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d30a87b9-90fb-35b2-e053-2995a90aea2c": {
      "match": "brand_token",
      "title": "KEVEYIS (DICHLORPHENAMIDE) TABLET [XERIS PHARMACEUTICALS, INC.]",
      "spl_version": "9",
      "published_date": "2026-03-05"
    }
  },
  "productid": "72065-001_1a581a6b-8813-42ed-8892-21c2341b62c0",
  "productndc": "72065-001",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "011366",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Aug 7, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICHLORPHENAMIDE",
  "proprietary_name": "Keveyis",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA011366",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dichlorphenamide",
  "start_marketing_date": "20211213",
  "active_numerator_strength": "50"
}

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