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United States · US · US:52652-4001_461e7195-6963-5694-e063-6294a90ab583
Epaned
Orange BookUNIISPLATC C09AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC09AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115265240011150 mL in 1 BOTTLE (52652-4001-1)
Annotations
UNII (FDA Substance ID)
9O25354EPJ
ENALAPRIL MALEATE
RxCUI 203123
Orange Book
N208686
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9O25354EPJ",
"rxcui": "203123",
"inchikey": "OYFJQPXVCSSHAI-QFPUQLAESA-N",
"display_name": "ENALAPRIL MALEATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e6dbda02-779e-420c-893d-d0fea09432be": {
"match": "brand_token",
"title": "EPANED (ENALAPRIL MALEATE) SOLUTION [AZURITY PHARMACEUTICALS, INC.]",
"spl_version": "8",
"published_date": "2025-12-18"
}
},
"productid": "52652-4001_461e7195-6963-5694-e063-6294a90ab583",
"productndc": "52652-4001",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "208686",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Sep 20, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENALAPRIL MALEATE",
"proprietary_name": "Epaned",
"active_ingred_unit": "mg/mL",
"application_number": "NDA208686",
"marketing_category": "NDA",
"nonproprietary_name": "enalapril maleate",
"start_marketing_date": "20161003",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code C09AA02.
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