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United States · US · US:0187-0146_b97cbaf1-3abe-4f23-b2a0-4ff43f8bf5cb

Vaseretic

Orange BookUNIIATC C09AA

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

Identification

ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeC09AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0187014601
    100 TABLET in 1 BOTTLE (0187-0146-01)

Annotations

UNII (FDA Substance ID)
9O25354EPJ
ENALAPRIL MALEATE
RxCUI 203123
Orange Book
N019221
ABAB
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",
  "productid": "0187-0146_b97cbaf1-3abe-4f23-b2a0-4ff43f8bf5cb",
  "productndc": "0187-0146",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "019221",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;25MG",
        "product_no": "001",
        "approval_date": "Oct 31, 1986"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG;12.5MG",
        "product_no": "003",
        "approval_date": "Jul 12, 1995"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE",
  "proprietary_name": "Vaseretic",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA019221",
  "marketing_category": "NDA",
  "nonproprietary_name": "enalapril maleate and hydrochlorothiazide",
  "start_marketing_date": "19861031",
  "active_numerator_strength": "10; 25"
}

Related drugs

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