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United States · US · US:71335-3136_759e1287-5d59-4452-bfbd-e9ef084ae031

ENALAPRIL MALEATE

Orange BookUNIISPLATC C09AA02

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC09AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7133531361
    60 TABLET in 1 BOTTLE (71335-3136-1)
  • ndc11
    7133531362
    30 TABLET in 1 BOTTLE (71335-3136-2)
  • ndc11
    7133531363
    100 TABLET in 1 BOTTLE (71335-3136-3)
  • ndc11
    7133531364
    90 TABLET in 1 BOTTLE (71335-3136-4)
  • ndc11
    7133531365
    120 TABLET in 1 BOTTLE (71335-3136-5)

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": "71335-3136_759e1287-5d59-4452-bfbd-e9ef084ae031",
  "productndc": "71335-3136",
  "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": "10"
}

Related drugs

Other records sharing ATC code C09AA02.

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