ENALAPRIL MALEATE

Orange BookUNIISPLATC C09AA02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerRising Pharma Holdings, Inc.

CountryUS (United States)

ATC codeC09AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6498068801
100 TABLET in 1 BOTTLE (64980-688-01)
ndc11
6498068810
1000 TABLET in 1 BOTTLE (64980-688-10)

Annotations

UNII (FDA Substance ID)

9O25354EPJ

ENALAPRIL MALEATE

RxCUI 203123

Orange Book

A218531

ABABABAB

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": "64980-688_6f4c73c0-8b68-485d-87f6-cd77746aada8",
  "productndc": "64980-688",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218531",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Sep 19, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Sep 19, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Sep 19, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Sep 19, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENALAPRIL MALEATE",
  "proprietary_name": "ENALAPRIL MALEATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218531",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ENALAPRIL MALEATE",
  "start_marketing_date": "20250224",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C09AA02.

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