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United States · US · US:67544-739_81155b23-9294-4758-80c8-5e33c4024868

Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AX01

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeC03AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6754473960
    90 CAPSULE, GELATIN COATED in 1 PACKAGE (67544-739-60)

Annotations

UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
N020504
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": "67544-739_81155b23-9294-4758-80c8-5e33c4024868",
  "productndc": "67544-739",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "020504",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Dec 27, 1996"
      }
    ],
    "appl_type": "N"
  },
  "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": "NDA020504",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Hydrochlorothiazide",
  "start_marketing_date": "19961227",
  "active_numerator_strength": "12.5"
}

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