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United States · US · US:82804-972_4c1a2fb9-133d-4bd5-a336-e47d54f22c97

Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AX01

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeC03AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    8280497200
    100 TABLET in 1 BOTTLE (82804-972-00)
  • ndc11
    8280497211
    1000 TABLET in 1 BOTTLE (82804-972-11)
  • ndc11
    8280497230
    30 TABLET in 1 BOTTLE (82804-972-30)
  • ndc11
    8280497255
    500 TABLET in 1 BOTTLE (82804-972-55)
  • ndc11
    8280497260
    60 TABLET in 1 BOTTLE (82804-972-60)
  • ndc11
    8280497272
    120 TABLET in 1 BOTTLE (82804-972-72)
  • ndc11
    8280497290
    90 TABLET in 1 BOTTLE (82804-972-90)

Annotations

UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A087059
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Hydrochlorothiazide Capsule
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": {
    "a013211e-b8f8-426d-8e55-e86193f0634e": {
      "match": "brand_token",
      "title": "HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "9",
      "published_date": "2026-05-21"
    }
  },
  "productid": "82804-972_4c1a2fb9-133d-4bd5-a336-e47d54f22c97",
  "productndc": "82804-972",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "087059",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE",
  "shortage_reason": "Hydrochlorothiazide Capsule",
  "shortage_status": "current",
  "proprietary_name": "Hydrochlorothiazide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA087059",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrochlorothiazide",
  "start_marketing_date": "20200925",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code C03AX01.

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