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United States · US · US:60758-670_41079403-219e-4194-90e8-3b9b83dcf298
DAPSONE
In shortageOrange BookUNIISPLATC J04BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPacific Pharma, Inc.
CountryUS (United States)
ATC codeJ04BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1160758670301 TUBE in 1 CARTON (60758-670-30) / 30 g in 1 TUBE
- ndc1160758670601 TUBE in 1 CARTON (60758-670-60) / 60 g in 1 TUBE
- ndc1160758670901 TUBE in 1 CARTON (60758-670-90) / 90 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
N021794
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": "60758-670_41079403-219e-4194-90e8-3b9b83dcf298",
"productndc": "60758-670",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "021794",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "5%",
"product_no": "001",
"approval_date": "Jul 7, 2005"
}
],
"appl_type": "N"
},
"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": "NDA021794",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "dapsone",
"start_marketing_date": "20171018",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J04BA02.
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