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United States · US · US:62332-663_5fa76202-2367-486b-bfe8-73f3dcd5a574
Dapsone
In shortageOrange BookUNIISPLATC J04BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ04BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1162332663301 BOTTLE, PUMP in 1 CARTON (62332-663-30) / 30 g in 1 BOTTLE, PUMP
- ndc1162332663601 BOTTLE, PUMP in 1 CARTON (62332-663-60) / 60 g in 1 BOTTLE, PUMP
- ndc1162332663901 BOTTLE, PUMP in 1 CARTON (62332-663-90) / 90 g in 1 BOTTLE, PUMP
Annotations
UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
A215718
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": "62332-663_5fa76202-2367-486b-bfe8-73f3dcd5a574",
"productndc": "62332-663",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "215718",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7.5%",
"product_no": "001",
"approval_date": "Oct 27, 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": "ANDA215718",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapsone",
"start_marketing_date": "20231030",
"active_numerator_strength": "75"
}Related drugs
Other records sharing ATC code J04BA02.
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