Triamterene and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7077114740
1000 CAPSULE in 1 BOTTLE (70771-1474-0)
ndc11
7077114741
100 CAPSULE in 1 BOTTLE (70771-1474-1)
ndc11
7077114744
10 BLISTER PACK in 1 CARTON (70771-1474-4) / 10 CAPSULE in 1 BLISTER PACK (70771-1474-2)
ndc11
7077114745
500 CAPSULE in 1 BOTTLE (70771-1474-5)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A208358

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": "70771-1474_82aa9973-f70d-4c03-831e-b28f586e2915",
  "productndc": "70771-1474",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208358",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;37.5MG",
        "product_no": "001",
        "approval_date": "Feb 11, 2019"
      }
    ],
    "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": "ANDA208358",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Triamterene and Hydrochlorothiazide",
  "start_marketing_date": "20200303",
  "active_numerator_strength": "25; 37.5"
}

Related drugs

Other records sharing ATC code C03AA.

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