Back to search
🇺🇸

United States · US · US:13668-605_2c733874-9036-42d0-8820-d5a4a35b5adc

dapsone

In shortageOrange BookUNIISPLATC J04BA02

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

Identification

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

Packs · 2

  • ndc11
    1366860505
    1 BOTTLE, PUMP in 1 CARTON (13668-605-05) / 60 g in 1 BOTTLE, PUMP
  • ndc11
    1366860508
    1 BOTTLE, PUMP in 1 CARTON (13668-605-08) / 90 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
A214722
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": "TOPICAL",
  "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": "13668-605_2c733874-9036-42d0-8820-d5a4a35b5adc",
  "productndc": "13668-605",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "214722",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5%",
        "product_no": "001",
        "approval_date": "Feb 10, 2022"
      }
    ],
    "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/g",
  "application_number": "ANDA214722",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dapsone",
  "start_marketing_date": "20220210",
  "active_numerator_strength": "75"
}

Related drugs

Other records sharing ATC code J04BA02.

Access this data programmatically

Query dapsone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.