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United States · US · US:62559-414_052493c7-89a3-452e-8140-04dd95f0d9e2

Benazepril Hydrochloride and Hydrochlorothiazide

Orange BookUNIISPLATC C09AA

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

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC09AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6255941401
    100 TABLET in 1 BOTTLE (62559-414-01)

Annotations

UNII (FDA Substance ID)
N1SN99T69T
BENAZEPRIL HYDROCHLORIDE
RxCUI 235758
Orange Book
A076342
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": "62559-414_052493c7-89a3-452e-8140-04dd95f0d9e2",
  "productndc": "62559-414",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076342",
    "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": false,
        "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": "ANDA076342",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benazepril Hydrochloride and Hydrochlorothiazide",
  "start_marketing_date": "20221107",
  "active_numerator_strength": "5; 6.25"
}

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