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United States · US · US:68788-7683_6933b66c-f5bf-43b3-854f-73233228db3a

Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AX01

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

Identification

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

Packs · 5

  • ndc11
    6878876831
    100 CAPSULE in 1 BOTTLE (68788-7683-1)
  • ndc11
    6878876833
    30 CAPSULE in 1 BOTTLE (68788-7683-3)
  • ndc11
    6878876836
    60 CAPSULE in 1 BOTTLE (68788-7683-6)
  • ndc11
    6878876837
    7 CAPSULE in 1 BOTTLE (68788-7683-7)
  • ndc11
    6878876839
    90 CAPSULE in 1 BOTTLE (68788-7683-9)

Annotations

UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A203561
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": "68788-7683_6933b66c-f5bf-43b3-854f-73233228db3a",
  "productndc": "68788-7683",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "203561",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Jan 14, 2019"
      }
    ],
    "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": "ANDA203561",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrochlorothiazide",
  "start_marketing_date": "20200302",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code C03AX01.

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