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United States · US · US:0187-0143_1be6ec2b-1c20-4ff4-a8ff-cd23e3de9fa4

Vasotec

Orange BookUNIISPLATC C09AA02

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

Identification

ManufacturerBausch Health US LLC
CountryUS (United States)
ATC codeC09AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0187014310
    1000 TABLET in 1 BOTTLE (0187-0143-10)
  • ndc11
    0187014330
    30 TABLET in 1 BOTTLE (0187-0143-30)
  • ndc11
    0187014390
    90 TABLET in 1 BOTTLE (0187-0143-90)

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": {
    "39631f1f-5d19-43c1-b504-bf56d991ed97": {
      "match": "brand_token",
      "title": "VASOTEC (ENALAPRIL MALEATE) TABLET [BAUSCH HEALTH US LLC]",
      "spl_version": "15",
      "published_date": "2026-01-28"
    }
  },
  "productid": "0187-0143_1be6ec2b-1c20-4ff4-a8ff-cd23e3de9fa4",
  "productndc": "0187-0143",
  "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": "Vasotec",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018998",
  "marketing_category": "NDA",
  "nonproprietary_name": "Enalapril Maleate",
  "start_marketing_date": "19851224",
  "active_numerator_strength": "20"
}

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