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United States · US · US:78206-121_998b309b-7dde-4d62-b902-010dd83108fe

COZAAR

Orange BookUNIISPLATC C09CA01

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

Identification

ManufacturerOrganon LLC
CountryUS (United States)
ATC codeC09CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7820612101
    90 TABLET, FILM COATED in 1 BOTTLE (78206-121-01)

Annotations

UNII (FDA Substance ID)
3ST302B24A
LOSARTAN POTASSIUM
RxCUI 203160
Orange Book
N020386
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3ST302B24A",
    "rxcui": "203160",
    "inchikey": "OXCMYAYHXIHQOA-UHFFFAOYSA-N",
    "display_name": "LOSARTAN POTASSIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9949448f-c3b9-44ee-94ed-c1aca8c90f39": {
      "match": "brand_token",
      "title": "COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [ORGANON LLC]",
      "spl_version": "9",
      "published_date": "2026-01-21"
    }
  },
  "productid": "78206-121_998b309b-7dde-4d62-b902-010dd83108fe",
  "productndc": "78206-121",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020386",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Apr 14, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Apr 14, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Oct 13, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOSARTAN POTASSIUM",
  "proprietary_name": "COZAAR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020386",
  "marketing_category": "NDA",
  "nonproprietary_name": "losartan potassium",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "25"
}

Related drugs

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