🇺🇸
United States · US · US:68462-626_28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6
azelaic acid
Orange BookUNIISPLATC D10AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeD10AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168462626521 TUBE in 1 CARTON (68462-626-52) / 50 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
F2VW3D43YT
AZELAIC ACID
RxCUI 18602
Orange Book
A204637
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": "68462-626_28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6",
"productndc": "68462-626",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "204637",
"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",
"active_ingred_unit": "g/g",
"application_number": "ANDA204637",
"marketing_category": "ANDA",
"nonproprietary_name": "azelaic acid",
"start_marketing_date": "20181119",
"active_numerator_strength": ".15"
}Related drugs
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