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United States · US · US:16110-869_ae821f0c-ec53-4612-a505-e1aa9d73a158
AZELEX
Orange BookUNIISPLATC D10AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlmirall, LLC
CountryUS (United States)
ATC codeD10AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1116110869301 TUBE in 1 CARTON (16110-869-30) / 30 g in 1 TUBE
- ndc1116110869501 TUBE in 1 CARTON (16110-869-50) / 50 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
F2VW3D43YT
AZELAIC ACID
RxCUI 18602
Orange Book
N020428
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": "CUTANEOUS",
"spl_meta": {
"ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75": {
"match": "brand_token",
"title": "AZELEX (AZELAIC ACID) CREAM [ALMIRALL, LLC]",
"spl_version": "6",
"published_date": "2024-03-08"
}
},
"productid": "16110-869_ae821f0c-ec53-4612-a505-e1aa9d73a158",
"productndc": "16110-869",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "020428",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20%",
"product_no": "001",
"approval_date": "Sep 13, 1995"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZELAIC ACID",
"proprietary_name": "AZELEX",
"active_ingred_unit": "g/g",
"application_number": "NDA020428",
"marketing_category": "NDA",
"nonproprietary_name": "azelaic acid",
"start_marketing_date": "20180924",
"active_numerator_strength": ".2"
}Related drugs
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