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United States · US · US:68788-8294_fcd89393-6075-4b43-aa32-54f34f74f578

Chlorthalidone

Orange BookUNIISPLATC C03BA04

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC03BA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6878882943
    30 TABLET in 1 BOTTLE (68788-8294-3)
  • ndc11
    6878882949
    90 TABLET in 1 BOTTLE (68788-8294-9)

Annotations

UNII (FDA Substance ID)
Q0MQD1073Q
CHLORTHALIDONE
RxCUI 2409
Orange Book
A214129
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Q0MQD1073Q",
    "rxcui": "2409",
    "inchikey": "JIVPVXMEBJLZRO-UHFFFAOYSA-N",
    "display_name": "CHLORTHALIDONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "15dd224a-87ad-48dc-80b1-e8382a452c4c": {
      "match": "brand_token",
      "title": "CHLORTHALIDONE TABLET [MYLAN PHARMACEUTICALS INC.]",
      "spl_version": "13",
      "published_date": "2026-05-06"
    }
  },
  "productid": "68788-8294_fcd89393-6075-4b43-aa32-54f34f74f578",
  "productndc": "68788-8294",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214129",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Nov 27, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Nov 27, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORTHALIDONE",
  "proprietary_name": "Chlorthalidone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214129",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Chlorthalidone",
  "start_marketing_date": "20221129",
  "active_numerator_strength": "25"
}

Related drugs

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