ENALAPRIL MALEATE

Orange BookUNIISPLATC C09AA02

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

Identification

ManufacturerAmici Pharma, Inc

CountryUS (United States)

ATC codeC09AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6929254601
100 TABLET in 1 BOTTLE (69292-546-01)
ndc11
6929254610
1000 TABLET in 1 BOTTLE (69292-546-10)

Annotations

UNII (FDA Substance ID)

9O25354EPJ

ENALAPRIL MALEATE

RxCUI 203123

Orange Book

A075483

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": "69292-546_d6d5b131-5d92-41b7-829f-9de587a951d6",
  "productndc": "69292-546",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075483",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Aug 22, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Aug 22, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Aug 22, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Aug 22, 2000"
      }
    ],
    "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": "ANDA075483",
  "marketing_category": "ANDA",
  "nonproprietary_name": "enalapril maleate",
  "start_marketing_date": "20251015",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C09AA02.

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