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United States · US · US:16714-956_3980a223-560e-186f-e063-6394a90a0d68
Dapsone
In shortageOrange BookUNIISPLATC J04BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNORTHSTAR RX LLC
CountryUS (United States)
ATC codeJ04BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1116714956011 TUBE in 1 CARTON (16714-956-01) / 60 g in 1 TUBE
- ndc1116714956021 TUBE in 1 CARTON (16714-956-02) / 90 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
8W5C518302
DAPSONE
RxCUI 3108
Orange Book
A209506
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": "16714-956_3980a223-560e-186f-e063-6394a90a0d68",
"productndc": "16714-956",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "209506",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5%",
"product_no": "001",
"approval_date": "Oct 16, 2017"
}
],
"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": "ANDA209506",
"marketing_category": "ANDA",
"nonproprietary_name": "Dapsone",
"start_marketing_date": "20171016",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J04BA02.
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