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United States · US · US:51672-1389_3cf92843-22fd-ba71-e063-6294a90a1fc6
Azelaic Acid
Orange BookUNIISPLATC D10AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeD10AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151672138931 TUBE in 1 CARTON (51672-1389-3) / 50 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
F2VW3D43YT
AZELAIC ACID
RxCUI 18602
Orange Book
A210549
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": "51672-1389_3cf92843-22fd-ba71-e063-6294a90a1fc6",
"productndc": "51672-1389",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "210549",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15%",
"product_no": "001",
"approval_date": "Aug 23, 2019"
}
],
"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": "ANDA210549",
"marketing_category": "ANDA",
"nonproprietary_name": "Azelaic Acid",
"start_marketing_date": "20190823",
"active_numerator_strength": ".15"
}Related drugs
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