Benazepril Hydrochloride and Hydrochlorothiazide

Orange BookUNIISPLATC C09AA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeC09AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6846257801
100 TABLET, FILM COATED in 1 BOTTLE (68462-578-01)

Annotations

UNII (FDA Substance ID)

N1SN99T69T

BENAZEPRIL HYDROCHLORIDE

RxCUI 235758

Orange Book

A076631

ABABABAB

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": {
    "5de2ea54-877d-46e9-b4c2-bf1ab9d0f19c": {
      "match": "brand_token",
      "title": "BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "30",
      "published_date": "2026-05-20"
    }
  },
  "productid": "68462-578_51b0aed8-a229-4d2c-8fdf-aa957fddc41b",
  "productndc": "68462-578",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076631",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;6.25MG",
        "product_no": "001",
        "approval_date": "Feb 11, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;12.5MG",
        "product_no": "002",
        "approval_date": "Feb 11, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG;12.5MG",
        "product_no": "003",
        "approval_date": "Feb 11, 2004"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG;25MG",
        "product_no": "004",
        "approval_date": "Feb 11, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE",
  "proprietary_name": "Benazepril Hydrochloride and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076631",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benazepril Hydrochloride and Hydrochlorothiazide",
  "start_marketing_date": "20040211",
  "active_numerator_strength": "20; 12.5"
}

Related drugs

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