Benicar HCT

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerCosette Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0713094530
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0945-30)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

N021532

ABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Hydrochlorothiazide; Quinapril Hydrochloride Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "0J48LPH2TH",
    "rxcui": "5487",
    "inchikey": "JZUFKLXOESDKRF-UHFFFAOYSA-N",
    "display_name": "HYDROCHLOROTHIAZIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a90915ca-f9d3-4fff-8370-d5dc4cdfc521": {
      "match": "brand_token",
      "title": "BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [COSETTE PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-02"
    }
  },
  "productid": "0713-0945_4caff105-c8ff-7873-e063-6294a90a5bfc",
  "productndc": "0713-0945",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021532",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG;20MG",
        "product_no": "002",
        "approval_date": "Jun 5, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG;40MG",
        "product_no": "003",
        "approval_date": "Jun 5, 2003"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG;40MG",
        "product_no": "005",
        "approval_date": "Jun 5, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Benicar HCT",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021532",
  "marketing_category": "NDA",
  "nonproprietary_name": "olmesartan medoxomil-hydrochlorothiazide",
  "start_marketing_date": "20260401",
  "active_numerator_strength": "25; 40"
}

Related drugs

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