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United States · US · US:82804-989_9cfe5fe7-abc7-4f48-a597-1b1a5c70a354

Dapsone

In shortageOrange BookUNIISPLATC J04BA02

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ04BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    8280498900
    100 TABLET in 1 BOTTLE (82804-989-00)
  • ndc11
    8280498911
    1000 TABLET in 1 BOTTLE (82804-989-11)
  • ndc11
    8280498930
    30 TABLET in 1 BOTTLE (82804-989-30)
  • ndc11
    8280498955
    500 TABLET in 1 BOTTLE (82804-989-55)
  • ndc11
    8280498960
    60 TABLET in 1 BOTTLE (82804-989-60)
  • ndc11
    8280498964
    240 TABLET in 1 BOTTLE (82804-989-64)
  • ndc11
    8280498972
    120 TABLET in 1 BOTTLE (82804-989-72)
  • ndc11
    8280498978
    180 TABLET in 1 BOTTLE (82804-989-78)
  • ndc11
    8280498990
    90 TABLET in 1 BOTTLE (82804-989-90)

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": "82804-989_9cfe5fe7-abc7-4f48-a597-1b1a5c70a354",
  "productndc": "82804-989",
  "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA086842",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dapsone",
  "start_marketing_date": "20240116",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code J04BA02.

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