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United States · US · US:0591-0348_31975473-b876-48d4-81f4-b322137d8900

Triamterene and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeC03AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0591034801
    100 TABLET in 1 BOTTLE, PLASTIC (0591-0348-01)
  • ndc11
    0591034805
    500 TABLET in 1 BOTTLE, PLASTIC (0591-0348-05)
  • ndc11
    0591034810
    1000 TABLET in 1 BOTTLE, PLASTIC (0591-0348-10)

Annotations

UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A071851
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": "0591-0348_31975473-b876-48d4-81f4-b322137d8900",
  "productndc": "0591-0348",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "071851",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;75MG",
        "product_no": "001",
        "approval_date": "Nov 30, 1988"
      }
    ],
    "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": "ANDA071851",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Triamterene and Hydrochlorothiazide",
  "start_marketing_date": "19930923",
  "active_numerator_strength": "50; 75"
}

Related drugs

Other records sharing ATC code C03AA.

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