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United States · US · US:69238-1627_0622cdcc-1196-4a2f-8c85-6f34f0f97f9d
Dapsone
In shortageOrange BookUNIISPLATC J04BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeJ04BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1169238162761 BOTTLE, PUMP in 1 CARTON (69238-1627-6) / 60 g in 1 BOTTLE, PUMP
- ndc1169238162791 BOTTLE, PUMP in 1 CARTON (69238-1627-9) / 90 g in 1 BOTTLE, PUMP
Annotations
UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
A212701
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": "69238-1627_0622cdcc-1196-4a2f-8c85-6f34f0f97f9d",
"productndc": "69238-1627",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "212701",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7.5%",
"product_no": "001",
"approval_date": "May 31, 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": "ANDA212701",
"marketing_category": "ANDA",
"nonproprietary_name": "Daspone",
"start_marketing_date": "20230602",
"active_numerator_strength": "75"
}Related drugs
Other records sharing ATC code J04BA02.
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