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United States · US · US:83098-101_2127568d-553c-c142-e063-6394a90a4ef7

Dapsone 100 mg

In shortageOrange BookUNIISPLATC J04BA02

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

Identification

ManufacturerEverest Life Sciences. LLC
CountryUS (United States)
ATC codeJ04BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8309810101
    100 TABLET in 1 BOTTLE (83098-101-01)
  • ndc11
    8309810103
    30 TABLET in 1 BOTTLE (83098-101-03)

Annotations

UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
A086842
AB
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": "83098-101_2127568d-553c-c142-e063-6394a90a4ef7",
  "productndc": "83098-101",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "086842",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAPSONE",
  "shortage_reason": "Dapsone Gel",
  "shortage_status": "current",
  "proprietary_name": "Dapsone 100 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA086842",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dapsone Tablets",
  "start_marketing_date": "20240901",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code J04BA02.

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