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United States · US · US:55289-090_41999499-b90e-0afa-e063-6294a90aea28

Triamterene and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC03AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5528909015
    15 TABLET in 1 BOTTLE, PLASTIC (55289-090-15)
  • ndc11
    5528909030
    30 TABLET in 1 BOTTLE, PLASTIC (55289-090-30)
  • ndc11
    5528909090
    90 TABLET in 1 BOTTLE, PLASTIC (55289-090-90)

Annotations

UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A073449
AB
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": "55289-090_41999499-b90e-0afa-e063-6294a90aea28",
  "productndc": "55289-090",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "073449",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;37.5MG",
        "product_no": "001",
        "approval_date": "Sep 23, 1993"
      }
    ],
    "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": "ANDA073449",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Triamterene and Hydrochlorothiazide",
  "start_marketing_date": "19930923",
  "active_numerator_strength": "25; 37.5"
}

Related drugs

Other records sharing ATC code C03AA.

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