Enalapril Maleate

Orange BookUNIISPLATC C09AA02

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

Identification

ManufacturerOCEANSIDE PHARMACEUTICALS

CountryUS (United States)

ATC codeC09AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6868271001
100 TABLET in 1 BOTTLE (68682-710-01)
ndc11
6868271010
1000 TABLET in 1 BOTTLE (68682-710-10)

Annotations

UNII (FDA Substance ID)

9O25354EPJ

ENALAPRIL MALEATE

RxCUI 203123

Orange Book

N018998

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": "68682-710_6771388d-89b3-43ec-b69e-9cebeaa2a00a",
  "productndc": "68682-710",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "018998",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 24, 1985"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Dec 24, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Dec 24, 1985"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "005",
        "approval_date": "Jul 26, 1988"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENALAPRIL MALEATE",
  "proprietary_name": "Enalapril Maleate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018998",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Enalapril Maleate",
  "start_marketing_date": "19880726",
  "active_numerator_strength": "2.5"
}

Related drugs

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