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United States · US · US:21922-018_4805ec1d-1a52-438d-8601-2878f5f40e08
Dapsone
In shortageOrange BookUNIISPLATC J04BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEncube Ethicals, Inc.
CountryUS (United States)
ATC codeJ04BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1121922018071 TUBE in 1 CARTON (21922-018-07) / 60 g in 1 TUBE
- ndc1121922018081 TUBE in 1 CARTON (21922-018-08) / 90 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
A212383
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": "21922-018_4805ec1d-1a52-438d-8601-2878f5f40e08",
"productndc": "21922-018",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "212383",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5%",
"product_no": "001",
"approval_date": "Oct 13, 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/g",
"application_number": "ANDA212383",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapsone Gel, 5%",
"start_marketing_date": "20231016",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J04BA02.
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