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United States · US · US:30698-450_40029d07-adfa-0cc3-e063-6294a90a4cd5

Lotensin

Orange BookUNIISPLATC C09AA07

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

Identification

ManufacturerValidus Pharmaceuticals LLC
CountryUS (United States)
ATC codeC09AA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3069845001
    100 TABLET in 1 BOTTLE (30698-450-01)

Annotations

UNII (FDA Substance ID)
N1SN99T69T
BENAZEPRIL HYDROCHLORIDE
RxCUI 235758
Orange Book
N019851
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": "30698-450_40029d07-adfa-0cc3-e063-6294a90a4cd5",
  "productndc": "30698-450",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "019851",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jun 25, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jun 25, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Jun 25, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "Jun 25, 1991"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENAZEPRIL HYDROCHLORIDE",
  "proprietary_name": "Lotensin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019851",
  "marketing_category": "NDA",
  "nonproprietary_name": "benazepril hydrochloride",
  "start_marketing_date": "19910621",
  "active_numerator_strength": "40"
}

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