🇺🇸
United States · US · US:59651-945_5773bc55-511b-4168-a917-7c1f69e0853e
ECONAZOLE NITRATE
Orange BookUNIISPLATC D01AC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeD01AC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1159651945141 TUBE in 1 CARTON (59651-945-14) / 15 g in 1 TUBE
- ndc1159651945301 TUBE in 1 CARTON (59651-945-30) / 30 g in 1 TUBE
- ndc1159651945851 TUBE in 1 CARTON (59651-945-85) / 85 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
H438WYN10E
ECONAZOLE NITRATE
RxCUI 142434
Orange Book
A210364
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "H438WYN10E",
"rxcui": "142434",
"inchikey": "DDXORDQKGIZAME-UHFFFAOYSA-N",
"display_name": "ECONAZOLE NITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"74e5bbc9-eaea-405e-b64b-b3527c5ea084": {
"match": "brand_token",
"title": "ECONAZOLE NITRATE CREAM [AUROBINDO PHARMA LIMITED]",
"spl_version": "2",
"published_date": "2026-05-13"
}
},
"productid": "59651-945_5773bc55-511b-4168-a917-7c1f69e0853e",
"productndc": "59651-945",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "210364",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1%",
"product_no": "001",
"approval_date": "Apr 18, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ECONAZOLE NITRATE",
"proprietary_name": "ECONAZOLE NITRATE",
"active_ingred_unit": "mg/g",
"application_number": "ANDA210364",
"marketing_category": "ANDA",
"nonproprietary_name": "ECONAZOLE NITRATE",
"start_marketing_date": "20260313",
"active_numerator_strength": "10"
}Related drugs
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