CANDESARTAN CILEXETIL

Orange BookUNIISPLATC C09CA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC09CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6362998421
30 TABLET in 1 BOTTLE (63629-9842-1)
ndc11
6362998422
90 TABLET in 1 BOTTLE (63629-9842-2)

Annotations

UNII (FDA Substance ID)

R85M2X0D68

CANDESARTAN CILEXETIL

RxCUI 135481

Orange Book

A210302

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "R85M2X0D68",
    "rxcui": "135481",
    "inchikey": "GHOSNRCGJFBJIB-UHFFFAOYSA-N",
    "display_name": "CANDESARTAN CILEXETIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "76630807-9717-44be-946d-756038cf677e": {
      "match": "brand_token",
      "title": "CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]",
      "spl_version": "9",
      "published_date": "2026-04-21"
    }
  },
  "productid": "63629-9842_fa56d3f2-c4d2-4bc1-998d-82d0e6a56e98",
  "productndc": "63629-9842",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210302",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Dec 4, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Dec 4, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "16MG",
        "product_no": "003",
        "approval_date": "Dec 4, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CANDESARTAN CILEXETIL",
  "proprietary_name": "CANDESARTAN CILEXETIL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210302",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CANDESARTAN CILEXETIL",
  "start_marketing_date": "20181205",
  "active_numerator_strength": "16"
}

Related drugs

Other records sharing ATC code C09CA.

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