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United States · US · US:68788-8320_7d1e258b-a9f1-4910-81df-2e6df683479d

Enalapril Maleate

Orange BookUNIISPLATC C09AA02

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC09AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6878883201
    100 TABLET in 1 BOTTLE (68788-8320-1)
  • ndc11
    6878883203
    30 TABLET in 1 BOTTLE (68788-8320-3)
  • ndc11
    6878883206
    60 TABLET in 1 BOTTLE (68788-8320-6)
  • ndc11
    6878883209
    90 TABLET in 1 BOTTLE (68788-8320-9)

Annotations

UNII (FDA Substance ID)
9O25354EPJ
ENALAPRIL MALEATE
RxCUI 203123
Orange Book
A213273
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": "68788-8320_7d1e258b-a9f1-4910-81df-2e6df683479d",
  "productndc": "68788-8320",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213273",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Jul 7, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Jul 7, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Jul 7, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Jul 7, 2022"
      }
    ],
    "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": "ANDA213273",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Enalapril Maleate",
  "start_marketing_date": "20230124",
  "active_numerator_strength": "20"
}

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