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United States · US · US:30698-453_4b9222f7-7b31-4781-e063-6394a90ab188

Lotensin HCT

Orange BookUNIISPLATC C09AA

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

Identification

ManufacturerValidus Pharmaceuticals LLC
CountryUS (United States)
ATC codeC09AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3069845301
    100 TABLET in 1 BOTTLE (30698-453-01)

Annotations

UNII (FDA Substance ID)
N1SN99T69T
BENAZEPRIL HYDROCHLORIDE
RxCUI 235758
Orange Book
N020033
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "N1SN99T69T",
    "rxcui": "235758",
    "inchikey": "VPSRQEHTHIMDQM-FKLPMGAJSA-N",
    "display_name": "BENAZEPRIL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "94c4536f-e28e-48b1-8336-b3939917e99d": {
      "match": "brand_token",
      "title": "LOTENSIN HCT (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]",
      "spl_version": "15",
      "published_date": "2026-02-26"
    }
  },
  "productid": "30698-453_4b9222f7-7b31-4781-e063-6394a90ab188",
  "productndc": "30698-453",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020033",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "May 19, 1992"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;12.5MG",
        "product_no": "002",
        "approval_date": "May 19, 1992"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG;25MG",
        "product_no": "003",
        "approval_date": "May 19, 1992"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG;12.5MG",
        "product_no": "004",
        "approval_date": "May 19, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE",
  "proprietary_name": "Lotensin HCT",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA020033",
  "marketing_category": "NDA",
  "nonproprietary_name": "benazepril hydrochloride and hydrochlorothiazide",
  "start_marketing_date": "19920530",
  "active_numerator_strength": "20; 12.5"
}

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