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United States · US · US:59651-529_2b0fd0eb-c717-4d3d-8c1a-5445bf64a7a2

ENALAPRIL MALEATE

Orange BookUNIISPLATC C09AA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC09AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5965152955
    1 BOTTLE in 1 CARTON (59651-529-55) / 150 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
9O25354EPJ
ENALAPRIL MALEATE
RxCUI 203123
Orange Book
A216458
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": {
    "c1e4cd79-ece5-432c-bd3a-ed4633ccec70": {
      "match": "brand_token",
      "title": "ENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "1",
      "published_date": "2026-05-29"
    }
  },
  "productid": "59651-529_2b0fd0eb-c717-4d3d-8c1a-5445bf64a7a2",
  "productndc": "59651-529",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "216458",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Jan 8, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENALAPRIL MALEATE",
  "proprietary_name": "ENALAPRIL MALEATE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216458",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ENALAPRIL MALEATE",
  "start_marketing_date": "20240108",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code C09AA02.

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