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United States · US · US:62135-966_33eb8d96-1ab4-2d54-e063-6294a90a9339
Dapsone
In shortageOrange BookUNIISPLATC J04BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeJ04BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11621359663030 TABLET in 1 BOTTLE (62135-966-30)
Annotations
UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
A204074
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": "62135-966_33eb8d96-1ab4-2d54-e063-6294a90a9339",
"productndc": "62135-966",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204074",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG",
"product_no": "001",
"approval_date": "May 10, 2016"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "100MG",
"product_no": "002",
"approval_date": "May 10, 2016"
}
],
"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": "ANDA204074",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapsone",
"start_marketing_date": "20160510",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J04BA02.
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