triamterene and hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6838285601
100 TABLET in 1 BOTTLE (68382-856-01)
ndc11
6838285605
500 TABLET in 1 BOTTLE (68382-856-05)
ndc11
6838285610
1000 TABLET in 1 BOTTLE (68382-856-10)
ndc11
6838285677
10 BLISTER PACK in 1 CARTON (68382-856-77) / 10 TABLET in 1 BLISTER PACK (68382-856-30)

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": "68382-856_e0a51d55-991a-463a-a382-428f33488d77",
  "productndc": "68382-856",
  "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

Other records sharing ATC code C03AA.

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