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United States · US · US:0023-3670_8d6a6d88-5639-4b7b-a712-d0600de69b02
ACZONE
In shortageOrange BookUNIISPLATC J04BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeJ04BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11002336700315 TUBE in 1 CARTON (0023-3670-03) / 3 g in 1 TUBE
- ndc1100233670301 TUBE in 1 CARTON (0023-3670-30) / 30 g in 1 TUBE
- ndc1100233670601 TUBE in 1 CARTON (0023-3670-60) / 60 g in 1 TUBE
- ndc1100233670901 TUBE in 1 CARTON (0023-3670-90) / 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": {
"b7d605cf-bf84-461b-939b-1f773a4cba65": {
"match": "brand_token",
"title": "ACZONE (DAPSONE) GEL [ALLERGAN, INC.]",
"spl_version": "16",
"published_date": "2025-11-24"
}
},
"productid": "0023-3670_8d6a6d88-5639-4b7b-a712-d0600de69b02",
"productndc": "0023-3670",
"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": "ACZONE",
"active_ingred_unit": "mg/g",
"application_number": "NDA021794",
"marketing_category": "NDA",
"nonproprietary_name": "dapsone",
"start_marketing_date": "20090624",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J04BA02.
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