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United States · US · US:0378-0222_21d4a0c6-4112-42bd-8738-2df8d81debf1

Chlorthalidone

Orange BookUNIISPLATC C03BA04

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

Identification

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

Packs · 2

  • ndc11
    0378022201
    100 TABLET in 1 BOTTLE, PLASTIC (0378-0222-01)
  • ndc11
    0378022210
    1000 TABLET in 1 BOTTLE, PLASTIC (0378-0222-10)

Annotations

UNII (FDA Substance ID)
Q0MQD1073Q
CHLORTHALIDONE
RxCUI 2409
Orange Book
A086831
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": "0378-0222_21d4a0c6-4112-42bd-8738-2df8d81debf1",
  "productndc": "0378-0222",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "086831",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORTHALIDONE",
  "proprietary_name": "Chlorthalidone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA086831",
  "marketing_category": "ANDA",
  "nonproprietary_name": "chlorthalidone",
  "start_marketing_date": "19810226",
  "active_numerator_strength": "25"
}

Related drugs

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