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United States · US · US:82804-989_9cfe5fe7-abc7-4f48-a597-1b1a5c70a354
Dapsone
In shortageOrange BookUNIISPLATC J04BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ04BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 9
- ndc118280498900100 TABLET in 1 BOTTLE (82804-989-00)
- ndc1182804989111000 TABLET in 1 BOTTLE (82804-989-11)
- ndc11828049893030 TABLET in 1 BOTTLE (82804-989-30)
- ndc118280498955500 TABLET in 1 BOTTLE (82804-989-55)
- ndc11828049896060 TABLET in 1 BOTTLE (82804-989-60)
- ndc118280498964240 TABLET in 1 BOTTLE (82804-989-64)
- ndc118280498972120 TABLET in 1 BOTTLE (82804-989-72)
- ndc118280498978180 TABLET in 1 BOTTLE (82804-989-78)
- ndc11828049899090 TABLET in 1 BOTTLE (82804-989-90)
Annotations
UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
A086842
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": "ORAL",
"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": "82804-989_9cfe5fe7-abc7-4f48-a597-1b1a5c70a354",
"productndc": "82804-989",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "086842",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"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/1",
"application_number": "ANDA086842",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapsone",
"start_marketing_date": "20240116",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J04BA02.
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