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United States · US · US:65162-339_e09d2bfe-ca6f-4f12-ba61-993371b94478
Dapsone
In shortageOrange BookUNIISPLATC J04BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeJ04BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1165162339631 TUBE in 1 CARTON (65162-339-63) / 30 g in 1 TUBE
- ndc1165162339851 TUBE in 1 CARTON (65162-339-85) / 60 g in 1 TUBE
- ndc1165162339911 TUBE in 1 CARTON (65162-339-91) / 90 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
A209890
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": "65162-339_e09d2bfe-ca6f-4f12-ba61-993371b94478",
"productndc": "65162-339",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "209890",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5%",
"product_no": "001",
"approval_date": "Oct 19, 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": "ANDA209890",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapsone",
"start_marketing_date": "20231024",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J04BA02.
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