triamterene and hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7161060260
90 TABLET in 1 BOTTLE (71610-602-60)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A208360

ABAB

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": {
    "f3bc491a-961d-4a38-8a55-c4a03be05b74": {
      "match": "brand_token",
      "title": "TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "101",
      "published_date": "2026-05-20"
    }
  },
  "productid": "71610-602_a7634afa-7ea2-43dd-8fe4-520d827c2725",
  "productndc": "71610-602",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208360",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;37.5MG",
        "product_no": "001",
        "approval_date": "Jun 29, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;75MG",
        "product_no": "002",
        "approval_date": "Jun 29, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; TRIAMTERENE",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "triamterene and hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA208360",
  "marketing_category": "ANDA",
  "nonproprietary_name": "triamterene and hydrochlorothiazide",
  "start_marketing_date": "20180904",
  "active_numerator_strength": "25; 37.5"
}

Related drugs

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