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United States · US · US:63187-440_115d864c-11d8-4f8c-a00d-d0fc8ba38ee3

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 · 3

  • ndc11
    6318744030
    30 TABLET in 1 BOTTLE (63187-440-30)
  • ndc11
    6318744060
    60 TABLET in 1 BOTTLE (63187-440-60)
  • ndc11
    6318744090
    90 TABLET in 1 BOTTLE (63187-440-90)

Annotations

UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A040702
ABABAB
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": "63187-440_115d864c-11d8-4f8c-a00d-d0fc8ba38ee3",
  "productndc": "63187-440",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040702",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Mar 16, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Mar 16, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "003",
        "approval_date": "May 10, 2017"
      }
    ],
    "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": "ANDA040702",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrochlorothiazide",
  "start_marketing_date": "20070601",
  "active_numerator_strength": "25"
}

Related drugs

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