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United States · US · US:0591-0347_b062bc7e-af92-4648-aed1-e02568313e21

Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AX01

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeC03AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0591034701
    100 CAPSULE, GELATIN COATED in 1 BOTTLE (0591-0347-01)
  • ndc11
    0591034705
    500 CAPSULE, GELATIN COATED in 1 BOTTLE (0591-0347-05)

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": "0591-0347_b062bc7e-af92-4648-aed1-e02568313e21",
  "productndc": "0591-0347",
  "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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