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United States · US · US:83098-102_2127568d-553c-c142-e063-6394a90a4ef7
Dapsone 25 mg
In shortageOrange BookUNIISPLATC J04BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEverest Life Sciences. LLC
CountryUS (United States)
ATC codeJ04BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc118309810201100 TABLET in 1 BOTTLE (83098-102-01)
- ndc11830981020330 TABLET in 1 BOTTLE (83098-102-03)
Annotations
UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
A086841
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": "83098-102_2127568d-553c-c142-e063-6394a90a4ef7",
"productndc": "83098-102",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "086841",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "25MG",
"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 25 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA086841",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapsone Tablets",
"start_marketing_date": "20240901",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code J04BA02.
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