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United States · US · US:43547-397_d8ce29b2-7f3a-4944-bf9e-0fcebb25d3c4

Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AX01

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

Identification

ManufacturerSolco Healthcare U.S., LLC
CountryUS (United States)
ATC codeC03AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    4354739701
    10 TABLET in 1 BOTTLE, PLASTIC (43547-397-01)
  • ndc11
    4354739703
    30 TABLET in 1 BOTTLE, PLASTIC (43547-397-03)
  • ndc11
    4354739705
    50 TABLET in 1 BOTTLE, PLASTIC (43547-397-05)
  • ndc11
    4354739710
    100 TABLET in 1 BOTTLE, PLASTIC (43547-397-10)
  • ndc11
    4354739711
    1000 TABLET in 1 BOTTLE, PLASTIC (43547-397-11)
  • ndc11
    4354739715
    5000 TABLET in 1 BOTTLE, PLASTIC (43547-397-15)
  • ndc11
    4354739750
    500 TABLET in 1 BOTTLE, PLASTIC (43547-397-50)

Annotations

UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A040412
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": "43547-397_d8ce29b2-7f3a-4944-bf9e-0fcebb25d3c4",
  "productndc": "43547-397",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040412",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Mar 29, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Mar 29, 2002"
      }
    ],
    "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": "ANDA040412",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrochlorothiazide",
  "start_marketing_date": "20020329",
  "active_numerator_strength": "25"
}

Related drugs

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