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United States · US · US:83209-566_20e8edf4-4458-c1da-e063-6394a90aa891

Dapsone

In shortageOrange BookUNIISPLATC J04BA02

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

Identification

ManufacturerBoswell Pharmacy Services LLC d/b/a BPS Wholesale
CountryUS (United States)
ATC codeJ04BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8320956630
    30 TABLET in 1 BLISTER PACK (83209-566-30)

Annotations

UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
A207165
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": "83209-566_20e8edf4-4458-c1da-e063-6394a90aa891",
  "productndc": "83209-566",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207165",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "May 8, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Jul 20, 2023"
      }
    ],
    "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": "ANDA207165",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dapsone",
  "start_marketing_date": "20240830",
  "active_numerator_strength": "100"
}

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