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United States · US · US:50742-285_2757ac31-07b3-4df2-80cc-f9918606c08a

HEMICLOR

Orange BookUNIISPLATC C03BA04

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

Identification

ManufacturerIngenus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeC03BA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5074228530
    30 TABLET in 1 BOTTLE (50742-285-30)
  • ndc11
    5074228590
    90 TABLET in 1 BOTTLE (50742-285-90)

Annotations

UNII (FDA Substance ID)
Q0MQD1073Q
CHLORTHALIDONE
RxCUI 2409
Orange Book
N218647
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": {
    "3f0f3ee0-f5a6-4bda-8160-a77744e9fa46": {
      "match": "brand_token",
      "title": "HEMICLOR (CHLORTHALIDONE) TABLET [INGENUS PHARMACEUTICALS, LLC]",
      "spl_version": "1",
      "published_date": "2025-04-02"
    }
  },
  "productid": "50742-285_2757ac31-07b3-4df2-80cc-f9918606c08a",
  "productndc": "50742-285",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218647",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Mar 17, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORTHALIDONE",
  "proprietary_name": "HEMICLOR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218647",
  "marketing_category": "NDA",
  "nonproprietary_name": "chlorthalidone",
  "start_marketing_date": "20250317",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code C03BA04.

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