🇺🇸
United States · US · US:21922-038_433f2929-0ee4-4b1f-a548-eff7b66e7fb6
Azelaic Acid Gel
Orange BookUNIISPLATC D10AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEncube Ethicals, Inc.
CountryUS (United States)
ATC codeD10AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1121922038141 TUBE in 1 CARTON (21922-038-14) / 50 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
F2VW3D43YT
AZELAIC ACID
RxCUI 18602
Orange Book
A208724
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "F2VW3D43YT",
"rxcui": "18602",
"inchikey": "BDJRBEYXGGNYIS-UHFFFAOYSA-N",
"display_name": "AZELAIC ACID",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"9c151fc7-cb0b-4931-9c1b-0c29f46ac21f": {
"match": "brand_token",
"title": "AZELAIC ACID GEL (AZELAIC ACID) GEL [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2026-05-25"
}
},
"productid": "21922-038_433f2929-0ee4-4b1f-a548-eff7b66e7fb6",
"productndc": "21922-038",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "208724",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15%",
"product_no": "001",
"approval_date": "Nov 19, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZELAIC ACID",
"proprietary_name": "Azelaic Acid Gel",
"active_ingred_unit": "g/g",
"application_number": "ANDA208724",
"marketing_category": "ANDA",
"nonproprietary_name": "Azelaic Acid",
"start_marketing_date": "20231130",
"active_numerator_strength": ".15"
}Related drugs
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