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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

  • ndc11
    5265240011
    150 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"
}

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