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United States · US · US:72578-177_710844ec-6a59-45fa-b72a-4d75a4857361

Dapsone

In shortageOrange BookUNIISPLATC J04BA02

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

Identification

ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeJ04BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7257817701
    100 TABLET in 1 BOTTLE (72578-177-01)
  • ndc11
    7257817706
    30 TABLET in 1 BOTTLE (72578-177-06)

Annotations

UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
A220103
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dapsone Gel
Raw payload (JSON)
{
  "unii": {
    "unii": "8W5C518302",
    "rxcui": "3108",
    "inchikey": "MQJKPEGWNLWLTK-UHFFFAOYSA-N",
    "display_name": "DAPSONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "acd33f0b-8563-467a-93db-a11902331528": {
      "match": "brand_token",
      "title": "DAPSONE GEL [AUROBINDO PHARMA LIMITED]",
      "spl_version": "2",
      "published_date": "2026-05-20"
    }
  },
  "productid": "72578-177_710844ec-6a59-45fa-b72a-4d75a4857361",
  "productndc": "72578-177",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "220103",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Feb 26, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Feb 26, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAPSONE",
  "shortage_reason": "Dapsone Gel",
  "shortage_status": "current",
  "proprietary_name": "Dapsone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA220103",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dapsone",
  "start_marketing_date": "20260227",
  "active_numerator_strength": "25"
}

Related drugs

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